![KOA PROTECT OUR OCEAN LIFE OXYBENZONE FREE BROAD SPECTRUM SPF 30 UVA UVB PROTECTION SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KAPA'IHI, INC]](https://medic.hrt.org//dailymed/images/66e5eb1b-4ef0-459d-8428-b3e2f221bc85/Label5.jpg)
| NDC | 71889-350-08 |
| Set ID | 66e5eb1b-4ef0-459d-8428-b3e2f221bc85 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Kapa'ihi, Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- DRUG FACTS
- Active Ingredients
- USES:
- WARNINGS:
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DIRECTIONS:
Apply liberally 15-minutes before sun exposure. Reapply at least every two-hours or immediately after swimming. sweating or towel drying. SUN PROTECTION MEASURES, Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician.
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OTHER INGREDIENTS
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Seed Butter. Sodium Benzoate, Sodium Laurylglucosides Hydroxypropyl Sulfonate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Xanthan Gum.
- Other Information:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
KOA PROTECT OUR OCEAN LIFE OXYBENZONE FREE BROAD SPECTRUM SPF 30 UVA UVB PROTECTION SUNSCREEN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71889-350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 60 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) GREEN TEA LEAF (UNII: W2ZU1RY8B0) COCONUT OIL (UNII: Q9L0O73W7L) DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) SOYBEAN OIL (UNII: 241ATL177A) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) SODIUM BENZOATE (UNII: OJ245FE5EU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71889-350-08 1 in 1 CARTON 11/18/2017 1 236 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/18/2017 Labeler - Kapa'ihi, Inc (080938084)
