Label: SUN NATURAL SUNSCREEN- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71086-000-01 - Packager: Sun Naturals Inc
- Category: HUMAN OTC DRUG LABEL
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 November 18, 2016
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- 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 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 long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
Caprylic/Capric Triglyceride, Grape (Vitis vinifera) Seed Oil, Silica, Shea (Butyrospermum parkii) Butter, Candelilla (Euphorbia cerifera) Wax, Beeswax, Fragrance (Parfum), Jojoba (Simmondsia chinensis) Seed Oil, Tocopherol, Safflower (Carthamus tinctorius) Seed Oil, Cucumber (Cucumis sativus) Fruit Extract, Glycerin, Water (Aqua), Tea (Camellia sinensis) Leaf Extract, Rosehip (Rosa canina) Fruit Oil
- Package Labeling:
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INGREDIENTS AND APPEARANCE
SUN NATURAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71086-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 220 mg in 1 g Inactive Ingredients Ingredient Name Strength SHEA BUTTER (UNII: K49155WL9Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) TEA LEAF (UNII: GH42T47V24) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GRAPE SEED OIL (UNII: 930MLC8XGG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71086-000-01 1 in 1 BOX 11/16/2016 1 100 g in 1 TUBE; 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 11/16/2016 Labeler - Sun Naturals Inc (259934094)