Label: HAWAIIAN TROPIC MINERAL TRANSLUCENT SUNSCREEN POWDER SPF 30- zinc oxide powder
- NDC Code(s): 63354-820-21
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2023
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- Active Ingredients:
- Purpose
- Uses:
- Warnings:
-
Directions:
• Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: Ask a doctor • 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 -
Inactive Ingredients:
Calcium Aluminum Borosilicate, Silica, Ethylhexylglycerin, Sodium Dehydroacetate, Fragrance, Sea Salt, Ceramide NP, Ascorbyl
Palmitate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Iron Oxides. - Other Information
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC MINERAL TRANSLUCENT SUNSCREEN POWDER SPF 30
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-820 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.5 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ASCORBYL PALMITATE (UNII: QN83US2B0N) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CERAMIDE NP (UNII: 4370DF050B) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MANGO (UNII: I629I3NR86) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GUAVA (UNII: 74O70D6VG0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) SEA SALT (UNII: 87GE52P74G) PAPAYA (UNII: KU94FIY6JB) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-820-21 4.25 g in 1 TUBE; Type 0: Not a Combination Product 11/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/15/2021 Labeler - Edgewell Personal Care Brands LLC (151179769)
