Label: HAWAIIAN TROPIC- avobenzone octisalate octocrylene oil
- NDC Code(s): 63354-319-16
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 30, 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 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor
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Inactive Ingredients
Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric Acid, Daucus Carota Sativa (Carrot) Root Extract, Tocopheryl Acetate, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Aloe Barbadensis Leaf Extract, Red 17, Yellow 11.
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone octisalate octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-319 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) D&C RED NO. 17 (UNII: ND733RX3JN) COCOA BUTTER (UNII: 512OYT1CRR) CORN OIL (UNII: 8470G57WFM) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) TARTARIC ACID (UNII: W4888I119H) CARROT (UNII: L56Z1JK48B) HISTIDINE (UNII: 4QD397987E) ETHYLHEXYL PALMITATE (UNII: 2865993309) D&C YELLOW NO. 11 (UNII: 44F3HYL954) PAPAYA (UNII: KU94FIY6JB) MINERAL OIL (UNII: T5L8T28FGP) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) SOYBEAN OIL (UNII: 241ATL177A) GLYCERYL OLEATE (UNII: 4PC054V79P) BETA CAROTENE (UNII: 01YAE03M7J) GUAVA (UNII: 74O70D6VG0) MANGO (UNII: I629I3NR86) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ARGININE (UNII: 94ZLA3W45F) COCONUT OIL (UNII: Q9L0O73W7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-319-16 236 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/30/2023 Labeler - Edgewell Personal Care Brands LLC (151179769)
