Label: HAWAIIAN TROPIC ISLAND TANNING SUNSCREEN COCOA BUTTER SPF 4- avobenzone,octocrylene lotion
- NDC Code(s): 63354-771-16, 63354-771-17
- Packager: Edgewell Personal Care Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 1, 2023
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- Active Ingredients
- Purpose
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Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only
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Inactive ingredients
Water, Petrolatum, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Sodium Polyacrylate, Chlorphenesin, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Xanthan Gum, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Disodium EDTA, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC ISLAND TANNING SUNSCREEN COCOA BUTTER SPF 4
avobenzone,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-771 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) GUAVA (UNII: 74O70D6VG0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SHEA BUTTER (UNII: K49155WL9Y) COCOA BUTTER (UNII: 512OYT1CRR) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) PAPAYA (UNII: KU94FIY6JB) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PETROLATUM (UNII: 4T6H12BN9U) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL ALCOHOL (UNII: 936JST6JCN) POLYOXYL 100 STEARATE (UNII: YD01N1999R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) CHLORPHENESIN (UNII: I670DAL4SZ) MANGO (UNII: I629I3NR86) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-771-16 227 g in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2019 2 NDC:63354-771-17 306 g in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2019 10/26/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/13/2019 Labeler - Edgewell Personal Care Brands, LLC (151179769)