Label: HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene lotion
- NDC Code(s): 63354-453-54
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 4, 2023
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- Active Ingredients
- Purpose
- Uses
- Warnings
- 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 longsleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor.
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Inactive Ingredients
Water, Diisopropyl Adipate, Carthamus Tinctorius (Safflower) Seed Oil, Oryza Sativa (Rice) Starch, Glycerin, Alcohol Denat., Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Carbomer, Caprylyl Glycol, Sodium Hydroxide, Chlorphenesin, Fragrance, Gluconolactone, Disodium EDTA, Xanthan Gum, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Zea Mays (Corn) Oil, Sodium Ascorbyl Phosphate, Beta-Carotene, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Carica Papaya (Papaya) Fruit Extract.
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,homosalate,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-453 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3.5 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) ALCOHOL (UNII: 3K9958V90M) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) XANTHAN GUM (UNII: TTV12P4NEE) PAPAYA (UNII: KU94FIY6JB) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLUCONOLACTONE (UNII: WQ29KQ9POT) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) WATER (UNII: 059QF0KO0R) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) GLYCERIN (UNII: PDC6A3C0OX) MANGO (UNII: I629I3NR86) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CORN OIL (UNII: 8470G57WFM) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) SAFFLOWER OIL (UNII: 65UEH262IS) CHLORPHENESIN (UNII: I670DAL4SZ) PANTHENOL (UNII: WV9CM0O67Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) STARCH, RICE (UNII: 4DGK8B7I3S) GUAVA (UNII: 74O70D6VG0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BETA CAROTENE (UNII: 01YAE03M7J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-453-54 177 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2023 Labeler - Edgewell Personal Care Brands LLC (151179769)
