Label: HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene lotion
- NDC Code(s): 63354-494-16
- 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
- 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, Cetearyl Alcohol, Phenoxyethanol, Mica, Benzyl Alcohol, Diisopropyl Adipate, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Titanium Dioxide.
- Other Information
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,homosalate,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-494 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g in 100 g Inactive Ingredients Ingredient Name Strength PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL ALCOHOL (UNII: LKG8494WBH) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) XANTHAN GUM (UNII: TTV12P4NEE) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) PAPAYA (UNII: KU94FIY6JB) MANGO (UNII: I629I3NR86) GUAVA (UNII: 74O70D6VG0) PANTHENOL (UNII: WV9CM0O67Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCO GLUCOSIDE (UNII: ICS790225B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM HYDROXIDE (UNII: 55X04QC32I) SHEA BUTTER (UNII: K49155WL9Y) EDETATE DISODIUM (UNII: 7FLD91C86K) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) MICA (UNII: V8A1AW0880) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-494-16 236 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)
