Label: HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene lotion
- NDC Code(s): 63354-454-51
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
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 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 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:63354-454 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 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 g Inactive Ingredients Ingredient Name Strength STARCH, RICE (UNII: 4DGK8B7I3S) ALCOHOL (UNII: 3K9958V90M) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) PANTHENOL (UNII: WV9CM0O67Z) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CORN OIL (UNII: 8470G57WFM) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GUAVA (UNII: 74O70D6VG0) SAFFLOWER OIL (UNII: 65UEH262IS) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) MANGO (UNII: I629I3NR86) PAPAYA (UNII: KU94FIY6JB) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHLORPHENESIN (UNII: I670DAL4SZ) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLUCONOLACTONE (UNII: WQ29KQ9POT) BETA CAROTENE (UNII: 01YAE03M7J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-454-51 50 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)