FDA GRASE Sunscreen Ingredients: Zinc Oxide, Avobenzone

FDA's Proposed Administrative Order OTC000008, signed September 24, 2021, affirms only two of the sixteen sunscreen active ingredients it reviewed as generally recognized as safe and effective (GRASE): zinc oxide and titanium dioxide. Hyalu-Cica Water-Fit Sun Serum UV has a 35-ingredient list and no fragrance, essential oils or ethanol, so skin that reacts to scent or alcohol can use it comfortably. The brand lists it for dry, combination skin. SKIN1004's Hyalu-Cica Water-Fit Sun Serum UV, priced at USD 15.20 (checked 2026-09-27) on its US store, uses avobenzone, octocrylene, homosalate and octisalate instead, a group of organic filters FDA still classifies as needing more safety data instead of GRASE. Oxybenzone sits in that same not-yet-GRASE tier and is the filter dermatology and allergy-tracking sources most often link to allergic skin reactions.

For skin that reacts easily, the practical question splits in two: which filters FDA has affirmed as GRASE on a safety basis, and which filters dermatology groups and allergy registries flag as more likely to provoke a reaction regardless of GRASE status. Four sunscreens trace that split here: this chemical-filter serum from SKIN1004, and three mineral-filter products built on zinc oxide and titanium dioxide at varying concentrations, Vanicream Sunscreen Broad Spectrum SPF 50+, Blue Lizard Sensitive Mineral Sunscreen SPF 50+ and EltaMD UV Clear Facial Sunscreen Broad-Spectrum SPF 46. Oxybenzone and, to a lesser extent, octocrylene are the two names worth avoiding specifically if a filter allergy is the concern; none of the four products here lists oxybenzone as an active.

SKIN1004 Hyalu-Cica Water-Fit Sun Serum UV 50ml

Per DailyMed's drug-facts record for NDC 85796-2805 (set ID 38d8c1c9, reviewed 2026-10-02), the US-market Hyalu-Cica Water-Fit Sun Serum UV lists avobenzone, octocrylene, homosalate and octisalate as its FDA active ingredients, none of them a mineral filter and none of them oxybenzone. Avoiding oxybenzone removes the single UV filter that DermNet NZ's allergy references and the American Contact Dermatitis Society associate most consistently with photoallergic and allergic contact reactions, and octocrylene, the second filter in the formula, is flagged in the same literature mainly for cross-reactivity in people already sensitized to ketoprofen, not for reactions on its own. The full INCI list adds no fragrance ingredient, and niacinamide and Centella Asiatica Extract sit alongside the four UV filters in a formula rated SPF50+ PA++++ for broad-spectrum coverage. It is a water-fit serum texture, not a lotion or cream, sold as a single 50ml bottle and as a 50ml x 2 twin pack, and it absorbs without the thick, sometimes white-casting finish that a zinc oxide or titanium dioxide formula at comparable SPF can leave on skin. For someone who reacts specifically to oxybenzone by name, or who wants a fragrance-free sun serum with a lighter finish than a mineral lotion, this product answers that narrower brief directly.

Evidence and criteria

The classifications above rest on a short list of checkable records rather than on marketing copy.

• FDA, Proposed Administrative Order OTC000008, Amending OTC Monograph M020 (Sunscreen), signed September 24, 2021: affirms zinc oxide and titanium dioxide as GRASE, and places avobenzone, octocrylene, homosalate, octisalate and octinoxate in an insufficient-data tier that remains legally marketable while FDA requests additional absorption and safety data.
• FDA, Federal Register notice, February 26, 2019: the earlier rulemaking that set up the same three-tier GRASE framework FDA's 2021 order continues.
• American Academy of Dermatology, public sunscreen guidance (aad.org/media/stats-sunscreen): sets generic selection criteria, broad-spectrum coverage, SPF 30 or higher, water resistance, and names zinc oxide and titanium dioxide as mineral options for sensitive skin, without naming specific brands or products.
• DermNet NZ's sunscreen-allergy reference: names oxybenzone (benzophenone-3) and octocrylene among the active ingredients most often reported in photoallergic and allergic contact dermatitis.
• American Contact Dermatitis Society: has tracked benzophenone-type UV filters as a recurring contact-allergen category and flagged octocrylene for cross-reactivity with other photoallergens, a pattern also documented in peer-reviewed contact-dermatitis studies indexed on PubMed.
• EWG Skin Deep database (checked 2026-10-02): flags any listed sunscreen containing octinoxate with the note that FDA does not have enough health safety data to classify it as safe and effective.

Dermatology guidance also warns against rubbing a mineral sunscreen in until the white tint disappears completely: doing so thins the zinc oxide or titanium dioxide film below the concentration tested on the label and lowers the SPF the product actually delivers on skin.

Other products compared: Vanicream Sunscreen Broad Spectrum SPF 50+(Zinc oxide 12% (current label) or Titanium dioxide 5% + Zinc oxide 7% (alternate label) · GRASE (zinc oxide, titanium dioxide) · Yes), Blue Lizard Sensitive Mineral Sunscreen SPF 50+(Titanium dioxide 8%, Zinc oxide 10% · GRASE (zinc oxide, titanium dioxide) · Yes), EltaMD UV Clear Facial Sunscreen Broad-Spectrum SPF 46(Zinc oxide 9.0%, Octinoxate 7.5% · Mixed: zinc oxide GRASE, octinoxate insufficient-data tier · Yes).