Label: ADAPTASUN SEA AND TROPICS PROTECTIVE FACE CARE SPF 25- homosalate, octisalate, avobenzone cream
- NDC Code(s): 14324-025-00
- Packager: Naos USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (w/w)
- Use
- Warnings
-
Directions
Adults 18 years and older:
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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. ; and
- Wear long-sleeve shirts, pants, hats and sunglasses.
- Children under 6 months of age: ask a doctor.
- Other information
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Inactive ingredients
Aqua/water, Ethylhexyl Methoxycrylene, Glycerin, Silica, Tribehenin Peg-20 Esters, C12-15 Alkyl Benzoate, Dimethicone, Butyloctyl Salicylate, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-cresol, Cetearyl Alcohol, Vp/eicosene Copolymer, C20-22 Alkyl Phosphate, Creatine, Fragrance
(Parfum), Glyceryl Stearate, Glycyrrhetinic Acid, Mannitol, Methylpropanediol, Peg-100 Stearate, Pentylene Glycol, Soybean Glycerides, C20-22 Alcohols, Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer, Polysilicone-11, Caprylyl Glycol, 1,2-hexanediol, Acetyl Tyrosine, Aspartic Acid, Helianthus Annuus (Sunflower) Seed Oil, Xanthan Gum, Sodium Citrate, Sodium Dextran Sulfate, Sodium Hydroxide, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Butylene Glycol, Hydrolyzed Wheat Protein, Oleic Acid, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Propylene Glycol, Polysorbate 60, Sorbitan Isostearate, Aminoethanesulfinic Acid, Phenoxyethanol, Copper Gluconate, Carnosine, Disodium Adenosine Triphosphate, Artemia Extract, Medicago Sativa (Alfalfa) Extract, Laminaria Digitata Extract, Tocopherol, Acetyl Hexapeptide-1,
Dextran, Linalool, Hexyl Cinnamal, Hydroxycitronellal, Limonene, Benzyl Benzoate, Geraniol, Citronellol, Isoeugenol, Coumarin, Citral. - Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ADAPTASUN SEA AND TROPICS PROTECTIVE FACE CARE SPF 25
homosalate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14324-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 27 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) BENZOIC ACID (UNII: 8SKN0B0MIM) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) ALCOHOL (UNII: 3K9958V90M) C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) CREATINE (UNII: MU72812GK0) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ENOXOLONE (UNII: P540XA09DR) MANNITOL (UNII: 3OWL53L36A) METHYLPROPANEDIOL (UNII: N8F53B3R4R) PEG-100 STEARATE (UNII: YD01N1999R) PENTYLENE GLYCOL (UNII: 50C1307PZG) C20-22 ALCOHOLS (UNII: O4M0347C6A) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ACETYL L-TYROSINE (UNII: DA8G610ZO5) ASPARTIC ACID (UNII: 30KYC7MIAI) SUNFLOWER OIL (UNII: 3W1JG795YI) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) OLEOYL TYROSINE (UNII: 131P1BQX1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OLEIC ACID (UNII: 2UMI9U37CP) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) HYPOTAURINE (UNII: 5L08GE4332) PHENOXYETHANOL (UNII: HIE492ZZ3T) COPPER GLUCONATE (UNII: RV823G6G67) CARNOSINE (UNII: 8HO6PVN24W) MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) LAMINARIA DIGITATA (UNII: 15E7C67EE8) TOCOPHEROL (UNII: R0ZB2556P8) ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL BENZOATE (UNII: N863NB338G) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) ISOEUGENOL (UNII: 5M0MWY797U) COUMARIN (UNII: A4VZ22K1WT) CITRAL (UNII: T7EU0O9VPP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14324-025-00 1 in 1 CARTON 04/01/2022 09/30/2024 1 50 mL in 1 TUBE; 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 04/01/2022 09/30/2024 Labeler - Naos USA, Inc. (080727572)
