Label: DEWYVITA ZERO SPOT SUNSCREEN- octocrylene, homosalate, octisalate, avobenzone cream
- NDC Code(s): 60604-501-01, 60604-501-02
- Packager: reBom Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 21, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
■ Apply liberally 15 minutes before sun exposure ■ children under 6 months of age: Ask a doctor ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m.-2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating
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INACTIVE INGREDIENT
Water/Aqua, Butyloctyl Salicylate, Dipropylene Glycol, Silica, Nia cinamide, Diphenylsiloxy Phenyl Trimethicone, Sorbitan Olivate, Benzyl Glycol, Cetearyl Glucoside, Polymethylsilsesquioxane, Poly C10-30 Alkyl Acrylate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Cetearyl Alcohol, Ethylhexylglycerin, Adenosine, Centella Asiatica Extract, Rosa Damascena Flower Extract, Lactobacillus Ferment, Leontopodium Alpinum Callus Culture Extract, Butylene Glycol, Punica Granatum Fruit Extract, Madecassoside, 1,2-Hexanediol, Glycerin, Camellia Sinensis Leaf Water, Glutathione, Asiaticoside, Ethyl Hexanediol, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Madecassic Acid, Sodium Hyaluronate, Asiatic Acid, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Caprylyl Glycol, Sodium Hyaluronate DimethyIsilanol, Sodium Acetylated Hyaluronate
- OTHER SAFETY INFORMATION
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEWYVITA ZERO SPOT SUNSCREEN
octocrylene, homosalate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60604-501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.176 g in 24 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 1.752 g in 24 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.696 g in 24 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.16 g in 24 g Inactive Ingredients Ingredient Name Strength CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0) ASIATIC ACID (UNII: 9PA5A687X5) ROSA DAMASCENA FLOWER (UNII: JWB78P295A) DIPROPYLENE GLYCOL (UNII: E107L85C40) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V) LEONTOPODIUM ALPINUM (UNII: 7R4LQP52DM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SILICA (UNII: ETJ7Z6XBU4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) MADECASSOSIDE (UNII: CQ2F5O6YIY) ADENOSINE (UNII: K72T3FS567) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U) ARGININE (UNII: 94ZLA3W45F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYALURONIC ACID (UNII: S270N0TRQY) SODIUM HYALURONATE (UNII: YSE9PPT4TH) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SORBITAN OLIVATE (UNII: MDL271E3GR) CENTELLA ASIATICA (UNII: 7M867G6T1U) GLUTATHIONE (UNII: GAN16C9B8O) ASIATICOSIDE (UNII: PKO39VY215) ETHYL HEXANEDIOL (UNII: M9JGK7U88V) CETEARYL ALCOHOL (UNII: 2DMT128M1S) MADECASSIC ACID (UNII: M7O1N24J82) BENZYL GLYCOL (UNII: 06S8147L47) DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2) LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) PUNICA GRANATUM FRUIT JUICE (UNII: 99S671U9KB) DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60604-501-02 1 in 1 CONTAINER 05/15/2025 1 NDC:60604-501-01 50 g in 1 CASE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/15/2025 Labeler - reBom Co., Ltd. (695951708) Establishment Name Address ID/FEI Business Operations reBom Co., Ltd 695951708 manufacture(60604-501)
