Label: HAWAIIAN TROPIC- avobenzone,homosalate,octocrylene lotion
- NDC Code(s): 63354-621-24
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 2024
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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, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco-Glucoside, Chlorphenesin, Fragrance, Xanthan Gum, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Psidium Guajava Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate.
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,homosalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-621 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.2 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CHLORPHENESIN (UNII: I670DAL4SZ) MANGO (UNII: I629I3NR86) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BENZYL ALCOHOL (UNII: LKG8494WBH) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) GLYCERIN (UNII: PDC6A3C0OX) COCO GLUCOSIDE (UNII: ICS790225B) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) GUAVA (UNII: 74O70D6VG0) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) PAPAYA (UNII: KU94FIY6JB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-621-24 177 g in 1 TUBE; Type 0: Not a Combination Product 01/05/2022 10/31/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/05/2022 10/31/2026 Labeler - Edgewell Personal Care Brands LLC (151179769)
