Label: HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF30- titanium dioxide, zinc oxide oil
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- NDC Code(s): 63354-603-12
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 12, 2022
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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,
VP/Eicosene Copolymer, Alcohol Denat., Cocos Nucifera (Coconut) Oil, Glyceryl Stearate,
Polyhydroxystearic Acid, 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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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF30
titanium dioxide, zinc oxide oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.3 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) MICA (UNII: V8A1AW0880) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PAPAYA (UNII: KU94FIY6JB) PROPYLENE CARBONATE (UNII: 8D08K3S51E) KUKUI NUT OIL (UNII: TP11QR7B8R) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) MANGO (UNII: I629I3NR86) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GUAVA (UNII: 74O70D6VG0) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) DEHYDRATED ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-603-12 100 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2022 Labeler - Edgewell Personal Care Brands LLC (151179769) Establishment Name Address ID/FEI Business Operations Playtex Manufacturing Inc. (Ormond Beach) 963501502 manufacture(63354-603)
