Label: HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene lotion
- NDC Code(s): 63354-493-16
- 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 two 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 Ingredients
Water, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Mica, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Titanium Dioxide.
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,homosalate,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-493 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) PAPAYA (UNII: KU94FIY6JB) MANGO (UNII: I629I3NR86) COCO GLUCOSIDE (UNII: ICS790225B) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) GUAVA (UNII: 74O70D6VG0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) MICA (UNII: V8A1AW0880) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CHLORPHENESIN (UNII: I670DAL4SZ) SHEA BUTTER (UNII: K49155WL9Y) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) PANTHENOL (UNII: WV9CM0O67Z) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) XANTHAN GUM (UNII: TTV12P4NEE) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-493-16 236 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)
