Incomplete IL for an SPF?

Is this another example of a brand not complying with regulatory, especially for an OTC? 

I have not worked on sunscreens too much, but I can absolutely see how this is incomplete...no emulsifier? No polymer? 12% ZO just floating around and properly dispersed in this base? The brand owner is not being transparent and simply said "The Zinc is a hydrophilic and suspended in a lipid base for sheer application"    :D 

Thoughts? This is how it is listed on the bottle in the drug facts panel. 

Active Ingredients: 12% Micronized Zinc

Inactive Ingredients: Certified Organic Aloe Vera, Thioctic Acid (Alpha Lipoic Acid), Magnesium AscorbylPhosphate (Vitamin C), Panthenol (Vitamin B5), Dexpanthenol (Vitamin B12), Tocopheryl Acetate (Vitamin E), Ergocalciferol (Vitamin D), Vitis Vinifera (Grape) Seed Extract, Oenothera Biennis (Evening Primrose) Oil, Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Ulmus Fulva Bark (Slippery Elm) Extract, Borago Officinalis (Borage Oil) Seed, Alpha Bisabolol (Chamomile), Plantago Major (Plantain), Allantoin, Hyaluronic Acid, and Olive Squalane.

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Comments

  • Bill_TogeBill_Toge Member, Professional Chemist
    for starters, they've missed "oxide" from the active ingredient; I very much doubt metallic zinc would have a beneficial effect on blocking UV light
    also, there appears to be no solvent, water, or carrier oil(s) in it, so yes, I agree this list is most likely missing some crucial elements
    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • There aren't any SPF boosters (ethylhexyl salicylate, etc.) in there, either. It's missing the "juice" from the first inactive ingredient. Where are the preservatives?
    The brand owner definitely isn't being transparent.
  • PhilGeisPhilGeis Member, Professional formulator
    Suggest you write them - noting "Micronized Zinc" is not in the monograph.  Unless they've an NDA, this is an unapproved new drug that you've reported at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting
  • @Bill_Toge @RedCoast @PhilGeis thank you. It seems I have open a can of worms with the professionals that use this brand/product. It really irks me when I see these brands not playing by the rules, when the rest of us do. I have no regrets exposing this. Thanks, again!

  • PhilGeisPhilGeis Member, Professional formulator
    Thanks Matt - I'd do the same
  • RedCoastRedCoast Member
    edited April 23

    @Bill_Toge @RedCoast @PhilGeis thank you. It seems I have open a can of worms with the professionals that use this brand/product. It really irks me when I see these brands not playing by the rules, when the rest of us do. I have no regrets exposing this. Thanks, again!


    I feel the same way! The "natural" and "chemical-free" brands refuse to follow the rules the most! There were a couple of "natural" brands in the last decade that got nailed for inaccurate SPFs. I see tons of homemade sunscreens available to purchase on Etsy. They have zinc oxide, red raspberry seed oil, and just few other plant oils... they're definitely not safe! Ugggh!
  • @Pattsi The first one.  ;)

    It seems it's a stock private label formula, used by a few brands. Thanks for that search effort. 
  • MarkBroussardMarkBroussard Member, Professional Chemist
    @MattTheChemist:

    Since this is a brand selling to professional market and not the consumer market, the labeling rules for consumer market products do not apply.  Their LOI on the website may be different from the LOI on the packaging ... the FDA regulates labeling as it applies to what is required on the packaging.  So, the LOI on the website may not be in the order that you might see on their packaging.

    What they are doing here is dispersing the Zinc Oxide in the carrier oils, blending it in the Aloe Vera Juice and then jamming the whole thing together with higher molecular weight hyaluronic acid.  This approach is very process dependent and will most likely separate over time since it does not contain an emulsifier.

    So, I would not jump to any conclusions based on what you're seeing on their website.  However, if what you are seeing is coming directly from the packaging, then it would appear that there are some labeling errors.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
  • @MarkBroussard thank you, Mark! All good points. This one in particular is on the actual packaging. They sell it without any secondary outer components, and the cap has a shrink wrap on it. 

    The "feedback" I got from professionals using it is all positive, and no one has mentioned long term stability issues (that I know of). I was sent a few bottles (before I took a look at the deck) a few months ago, and the emulsion has not broken. Which is why my red flag got raised based on that IL. 

    If what you said is possible, how long would that type of emulsion be stable for without? I have definitely used HA as a polymer to emulsify TINY amounts of lipids, but I would never guessed that network would be strong enough to handle excess lipids, let alone that high of Zinc. 

    I appreciate your insight! 


  • MarkBroussardMarkBroussard Member, Professional Chemist
    @MattTheChemist

    It requires quite a high lipid load ... maybe in the 30% to 40% range.  Just my two, but I find it much easier to just use Sucrose Stearate to stabilize the emulsion and provide for better dispersion of the ZnO. 

    Grant used to make a ZnO dispersion in water which simplified the whole process for this type of product, but it has recently been discontinued.

    I'm not particularly fond of this type of "brute force" formula since I think not including an emuslifier is kind of an amateur approach to formulating.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
  • Bill_TogeBill_Toge Member, Professional Chemist
    I'm not particularly fond of this type of "brute force" formula since I think not including an emuslifier is kind of an amateur approach to formulating.
    that's a very diplomatic way of putting it; when I worked for a contract manufacturer, if a customer had wanted us to make a formula like that, I'd have used much more colourful terms
    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • @MattTheChemist:

    Since this is a brand selling to professional market and not the consumer market, the labeling rules for consumer market products do not apply.  Their LOI on the website may be different from the LOI on the packaging ... the FDA regulates labeling as it applies to what is required on the packaging.  So, the LOI on the website may not be in the order that you might see on their packaging.

    What they are doing here is dispersing the Zinc Oxide in the carrier oils, blending it in the Aloe Vera Juice and then jamming the whole thing together with higher molecular weight hyaluronic acid.  This approach is very process dependent and will most likely separate over time since it does not contain an emulsifier.

    So, I would not jump to any conclusions based on what you're seeing on their website.  However, if what you are seeing is coming directly from the packaging, then it would appear that there are some labeling errors.

    I'd been to dermatologists over the years, and they gave me sunscreens that I knew were stock formulations... but none of them ever had ILs like that!
    I know a few individuals that DIY sunscreens and they occasionally sell them online...they're not accurate with their labeling, either! That IL looked like what the DIYers I know would do, which is why I got very suspicious.
    I didn't expect a brand that targets professional markets to have such a suspicious label... but then again, it appears that brand target spas, and spas aren't necessarily known for their quality. :s
  • MarkBroussardMarkBroussard Member, Professional Chemist
    @Bill_Toge

    It is Dur Schtoopid ... LOL!
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
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