Label: HAWAIIAN TROPIC- avobenzone,octisalate,octocrylene lotion
- NDC Code(s): 63354-512-54
- 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
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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, Carthamus Tinctorius (Safflower) Seed Oil, Diisopropyl Adipate, Oryza Sativa (Rice) Starch, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol Denat., Phenoxyethanol, Carbomer, Caprylyl Glycol, Sodium Hydroxide, Chlorphenesin, Fragrance, Gluconolactone, Xanthan Gum, Disodium EDTA, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Zea Mays (Corn) Oil, Sodium Ascorbyl Phosphate, Beta-Carotene, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-512 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.2 g in 100 g Inactive Ingredients Ingredient Name Strength PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) WATER (UNII: 059QF0KO0R) STARCH, RICE (UNII: 4DGK8B7I3S) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) DEHYDRATED ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALOE VERA LEAF (UNII: ZY81Z83H0X) GUAVA (UNII: 74O70D6VG0) PAPAYA (UNII: KU94FIY6JB) GLUCONOLACTONE (UNII: WQ29KQ9POT) CORN OIL (UNII: 8470G57WFM) EDETATE DISODIUM (UNII: 7FLD91C86K) BETA CAROTENE (UNII: 01YAE03M7J) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SAFFLOWER OIL (UNII: 65UEH262IS) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) SODIUM HYDROXIDE (UNII: 55X04QC32I) PANTHENOL (UNII: WV9CM0O67Z) MANGO (UNII: I629I3NR86) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-512-54 177 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)
