Label: HAWAIIAN TROPIC- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 63354-929-54
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 31, 2024
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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Directions
•Apply liberally 15 minutes before sun exposure • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying •at least every 2 hours.
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., wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.
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Inactive Ingredient
Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethyl Methacrylate, Polymethylsilsesquioxane, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract.
- Other Information
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-929 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g Inactive Ingredients Ingredient Name Strength COCO GLUCOSIDE (UNII: ICS790225B) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) MANGO (UNII: I629I3NR86) CARICA PAPAYA WHOLE (UNII: S0U63B0Q51) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENETHYL BENZOATE (UNII: 0C143929GK) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) BENZYL ALCOHOL (UNII: LKG8494WBH) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) PARAFFIN (UNII: I9O0E3H2ZE) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM HYDROXIDE (UNII: 55X04QC32I) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) XANTHAN GUM (UNII: TTV12P4NEE) PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-929-54 177 g in 1 TUBE; Type 0: Not a Combination Product 10/11/2018 10/31/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/11/2018 10/31/2026 Labeler - Edgewell Personal Care Brands LLC (151179769)