The Honest Company faces a spate of consumer reports linking its SPF 30 broad-spectrum sunscreen lotion to serious sunburns and generating widespread media coverage that could challenge public perceptions about "natural" care and draw new attention to FDA's sunscreen oversight activities.

Media reports began picking up on the trend in late July, zeroing in on complaints from outraged consumers who have had adverse experiences with the zinc oxide-based product, marketed as a "highly effective and ultra-pure mineral sunscreen."

In a July 23 investigative piece, NBC Chicago highlighted an account from local mom Gretta Stabler whose 6-year-old daughter was badly burned after a day at the pool despite frequent reapplication of the Honest sunscreen.

The article included a roundup of similar grievances culled from online message boards and social-media sites, including allegations of "second-degree burns," "horrible burns" and "bright red burns all over."

Other disgruntled users have taken to Twitter with alleged photographic evidence of the Honest "all-natural" product's shortcomings.

Comments on Amazon.com since the sunscreen's introduction in early 2015 have been similarly negative, tracing back to early April, with reviewers lambasting the company and its product for alleged under-protective performance.

Amazon Shopper Reviews Of Honest Sunscreen Lotion Broad-Spectrum SPF 30

"Applied this generously, and twice, each of the 2 days we spent at the beach. All my kids still got very burned. … I thought I was splurging on a high quality, safer sunscreen, and it ended up ruining the rest of our vacation. My kids were miserable." (April 6)

"This is hands down the worst sunscreen ever. I've tried dozens of different sunscreens and words can't come close to describing how terrible this product compares even to the cheapest stuff you find at discount stores. … The sun protection from this product is about as good as no sunscreen. I was in the sun for less than an hour and my whole family was burnt." (April 8)

"Sunburn accelerant! I feel like filing a lawsuit against Honest. … We applied this before going to the beach and reapplied at the beach after swimming. We all got burned, especially my daughter. I feel like a bad parent." (May 13)

"I purchased this as I like many other Honest Company products. Unfortunately, it provides NO protection. My kids got so sunburned. As a parent, you feel horrible and responsible when these things happen." (May 18)

"DOES NOT WORK. I'm furious that, like the other reviewers, we were basically basting ourselves to be burned to a crisp. Even my husband who never ever burns is lobster red. … I'd rather have bought generic dollar store sunscreen and skipped frying my family." (May 24)

"Fiancé brought this 'sun protection' on our hike this past weekend. It is the equivalent of mayonnaise and appears to have intensified the sun. … Save your money – honestly." (June 2)

Honest was cofounded by actress Jessica Alba, which no doubt has fueled the firm's rapid growth, along with its message of social responsibility and commitment to providing good-for-you, non-toxic products in its mission to redefine the "family brand."

The Santa Monica, Calif.-based firm has booked rocketing sales since its inception in 2011 – reportedly up from $10 million in 2012 to an estimated $250 million in 2014 – and closed a $70 million funding round in summer 2014 at a valuation approaching $1 billion, the Wall Street Journal reported.

Honest is rumored to be eyeing an initial public offering, though no date has been pinpointed for its likely execution.

In response to criticism of the company's sunscreen, touted as containing "no synthetic chemical sunscreens," Alba and co-founder and Chief Products Officer Christopher Gavigan posted a statement on the firm's blog assuring fans that they take sun protection seriously and apply Honest sunscreen on their own children.

According to the pair, the product in question was subjected to "extensive third-party testing in accordance with government regulations" and passed all requirements.

They also note that the SPF 30 sunscreen lotion received top marks from the Environmental Working Group in its 2015 sunscreen review. EWG scored the sunscreen a 1 (best score) out of 10 based on its formulation, which the NGO said poses negligible health concerns and offers "excellent UVA protection and a good balance of UVA protection in relation to the SPF."

Company Maintains Regulatory Compliance

Honest's SPF 30 sunscreen lotion is a reformulated offering. The company went back to the drawing board to address complaints about its precursor and re-launched the product in early 2015.

Founders Alba and Gavigan explain in their blog post: "Our previous sunscreen formulation had a 40-minute water resistance and customers told us that it didn’t apply as easily as they would’ve liked. Based on our own experience and consumer feedback, we redesigned our Sunscreen Lotion for 80-minute water resistance and an improved formulation that allows for easier application and a lighter-weight feel."

The textural improvements seem not to have satisfied many users, who continue to carp about the product's unpleasant feel. Amazon reviewers claim it "feels like Crisco with baby powder in it," is "greasy like petroleum jelly" and leaves a white residue on the skin.

The latter is a common objection to zinc-based sunscreens that advances in nanotechnology have helped to address. Honest's formulation is "non-nano," however, according to its labeling.

Another change Honest made to the product is more relevant to the recent rash of adverse experiences. In response to comments on its Facebook page, the company says it reduced the zinc oxide content in its SPF 30 sunscreen – from 20% to 9.3% – as part of the reformulation effort, presumably to improve its sensory appeal.

Honest says it "added other ingredients which ultimately enabled us to provide the same level of efficacy with a lower amount of zinc oxide."

The firm could not be reached immediately for comment on its rationale behind the move, what sun-protective ingredients were added or the reformulation's potential contribution to sunburns reported by users.

Mainstream news outlets already are shifting blame from Honest to FDA and an "outdated" regulatory framework.

FDA's final monograph for OTC sunscreen drug products, which has been repeatedly stayed since its release in May 1999, includes zinc oxide up to 25% "when used alone or in combination with any monograph sunscreen active ingredient except avobenzone."

As initially published, the monograph required active-ingredient use to provide a minimum SPF value of not less than 2 as measured by specified testing procedures.

FDA has since updated its criteria with a final rule on sunscreen testing and labeling issued in June 2011, which requires products to meet broad-spectrum protection standards. Further, products with an SPF lower than 15 must bear a warning disclaiming any benefits regarding skin cancer or premature skin-aging prevention Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - HBW Insight, 20 June, 2011..

Honest says its SPF 30 sunscreen meets FDA's requirements, as demonstrated through independent third-party testing "against the protocols prescribed by the U.S. [FDA] monograph for over-the-counter sunscreen products."

If the company's product is in fact compliant with FDA standards, the sunscreen's alleged failure in consumer use could draw critical eyes to U.S. sunscreen regulations at a time when FDA already is under fire for perceived public-health disfavors.

Earlier this year, the agency issued proposed orders rejecting eight sunscreen time-and-extent applications following passage of the Sunscreen Innovation Act in late 2014, aimed at accelerating the agency's review work to provide consumers with next-generation sunscreen ingredients.

The development prompted a July 20 letter from Congress asking President Obama to intervene amidst a growing skin-cancer epidemic in the U.S. ([A#02150803005]).

Mainstream news outlets already are shifting blame from Honest to FDA and an "outdated" regulatory framework.

Formulation At Odds With Industry Practice?

While Honest may be regulatory-compliant, its lotion sunscreen formulation may deviate from common industry practice.

Zinc oxide (9.3%) is listed as the sole active ingredient in Honest's sunscreen product at issue. Other high-ranking natural-positioned sunscreens in EWG's 2015 roundup – which favored mineral-based offerings versus "chemical" sunscreens – feature zinc oxide in higher concentrations and often pair the ingredient with titanium dioxide for added protection.

Both Hain Celestial Group offerings Alba Botanica Very Emollient Mineral Sunscreen SPF 30 and JASON Sun Mineral Sunscreen Lotion SPF 30, for example, contain zinc oxide at 14.5%, plus 2% titanium dioxide.

Aubrey Organics Natural Sun Sunscreen SPF 26 features 12% zinc oxide, coupled with 5.6% titanium dioxide, while derma e Antioxidant Natural Sunscreen, Body, SPF 30 contains zinc oxide alone, but at a concentration of 12.5%.

All four products received scores of 1 or 2 in EWG's sunscreen report.

NBC Chicago's investigation found that mineral sunscreens on store shelves contained zinc oxide at levels between 18% and 25% when it figured as the sole active ingredient.

The media blitz around the Honest sunscreen episode could potentially trigger renewed conversation regarding natural personal care, with dermatologists already chiming in to underscore that "natural" does not mean safer and "chemical" is not an evil in itself.

Notably, while zinc oxide is recognized as effective in blocking both UVA and UVB light, research indicates that titanium dioxide is more effective in the UVB range, which is associated more with sunburns than longer-wave UVA, the chief contributor to skin aging.

Whether the absence of titanium dioxide from Honest's product, along with a relatively low zinc oxide concentration, played a role in recent sunburn reports is a matter of conjecture.

Honest's website says the SPF 30 sunscreen lotion is "out of stock." An SPF 30 sunscreen stick featuring 20% zinc oxide remains available.

As of late July, the company was stressing in communications that the number of complaints it had received on its own website about the lotion was "less than one-half of 1% of all its units sold at honest.com."

Regardless, the consumer backlash could weigh on the company's near-term performance and push back any IPO plans. Currently, Honest says it has been "reaching out to everyone who has posted on social media to assure you that we're committed to your safety and satisfaction."

Meanwhile, the media blitz around the episode could potentially trigger renewed conversation regarding natural personal care, with dermatologists already chiming in to underscore that "natural" does not mean safer and "chemical" is not an evil in itself.

Honest Co.'s Sunscreen Failure Triggers 'Natural' Discussion, FDA Criticism

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