Label: HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF 50- titanium dioxide, zinc oxide oil
- NDC Code(s): 63354-703-12
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
• shake well • 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 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 longsleeved shirts, pants, hats, and sunglasses • children under 6
months: Ask a doctor. -
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Alcohol Denat., Cocos Nucifera (Coconut) Oil, Sodium Chloride, Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Propylene Carbonate, Ethylhexylglycerin, Aleurites Moluccanus Seed Oil, Triethoxycaprylylsilane, Mica, Titanium Dioxide, Psidium Guajava Fruit Extract,
Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Iron Oxides. - Other Information
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF 50
titanium dioxide, zinc oxide oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.7 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.9 g in 100 g Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) ALUMINUM OXIDE (UNII: LMI26O6933) PROPYLENE CARBONATE (UNII: 8D08K3S51E) MICA (UNII: V8A1AW0880) GUAVA (UNII: 74O70D6VG0) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) PAPAYA (UNII: KU94FIY6JB) KUKUI NUT OIL (UNII: TP11QR7B8R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MANGO (UNII: I629I3NR86) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DEHYDRATED ALCOHOL (UNII: 3K9958V90M) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-703-12 100 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2022 08/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2022 08/31/2025 Labeler - Edgewell Personal Care Brands LLC (151179769)
