Label: ADAPTASUN SEA AND TROPICS PROTECTIVE BODY SPF 30- homosalate, octisalate, avobenzone lotion
- NDC Code(s): 14324-028-00
- 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
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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
Water, Ethylhexyl Methoxycrylene, Dicaprylyl Carbonate, Glycerin, Tribehenin Peg-20 Esters, Dimethicone, Butyloctyl Salicylate, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-Cresol, Silica, 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, Polysilicone-11, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Acetyl Tyrosine, Aspartic Acid, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Sodium Dextran Sulfate, Sodium Hydroxide, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Hydrolyzed Wheat Protein, Luffa Cylindrica Seed Oil, Linalool, Hexyl Cinnamal, Hydroxycitronellal, Oleaic Acid, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Propylene Glycol, Butylene Glycol, Aminoethanesulfinic Acid, Phenoxyethanol, Limonene, Benzyl Benzoate, Geraniol, Copper Gluconate, Citronellol, Carnosine, Tocopherol, Isoeugenol, Coumarin, Disodium Adenosine Triphosphate, Artemia Extract, Medicago Sativa (Alfalfa) Extract, Laminaria Digitata Extract, Citral, Acetyl Hexapeptide-1, Dextran. [ES867]
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INGREDIENTS AND APPEARANCE
ADAPTASUN SEA AND TROPICS PROTECTIVE BODY SPF 30
homosalate, octisalate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14324-028 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 BENZYL BENZOATE (UNII: N863NB338G) GERANIOL (UNII: L837108USY) COPPER GLUCONATE (UNII: RV823G6G67) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) CARNOSINE (UNII: 8HO6PVN24W) TOCOPHEROL (UNII: R0ZB2556P8) ISOEUGENOL (UNII: 5M0MWY797U) COUMARIN (UNII: A4VZ22K1WT) MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) LAMINARIA DIGITATA (UNII: 15E7C67EE8) CITRAL (UNII: T7EU0O9VPP) ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ) WATER (UNII: 059QF0KO0R) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GLYCERIN (UNII: PDC6A3C0OX) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ACETYL L-TYROSINE (UNII: DA8G610ZO5) ASPARTIC ACID (UNII: 30KYC7MIAI) SUNFLOWER OIL (UNII: 3W1JG795YI) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) OLEOYL TYROSINE (UNII: 131P1BQX1U) LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) OLEIC ACID (UNII: 2UMI9U37CP) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYPOTAURINE (UNII: 5L08GE4332) PHENOXYETHANOL (UNII: HIE492ZZ3T) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14324-028-00 1 in 1 CARTON 04/01/2023 09/30/2024 1 150 mL in 1 BOTTLE; 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 04/01/2023 09/30/2024 Labeler - Naos USA, Inc. (080727572)
