Label: SPORT NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58479-035-00, 58479-035-01 - Packager: Crossing Cultures LLC dba Goddess Garden
- 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 December 1, 2016
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- Active Ingredients
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- Warnings
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Directions
• Hold container 4 to 6 inches from skin. • Spray liberally and spread evenly by hand 15 minutes before sun exposure. • Should spray white lotion. • Rub in. • Do not spray directly onto face. Spray on hands and apply to face. • Do not apply in windy conditions. • Use in a well ventilated area. • Avoid inhaling or exposing others to spray. • Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours. • For use on children less than 6 months of age, consult 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 10am to 2pm. • Wear long-sleeved shirts, pants, hats and sunglasses.
- Other Information
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Inactive Ingredients
Aloe Barbadensis Leaf Juice*, Butyrospermum Parkii (Shea Butter)*, Caprylic/Capric Triglyceride (Coconut Oil), Caprylhydroxamic Acid, Carthamus Tinctorius (Safflower) Seed Oil1*, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Helianthus Annus (Sunflower) Seed Oil*, Lavandula Angustifolia (Lavender) Oil*, Polyhydroxystearic Acid, Sorbitan Oleate, Tocopherol (Vitamin E), Xanthan Gum *Certified Organic
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INGREDIENTS AND APPEARANCE
SPORT NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58479-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6 g in 100 g Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) SUNFLOWER OIL (UNII: 3W1JG795YI) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58479-035-00 96 g in 1 CAN; Type 0: Not a Combination Product 01/18/2016 2 NDC:58479-035-01 170 g in 1 CAN; Type 0: Not a Combination Product 01/18/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/18/2016 Labeler - Crossing Cultures LLC dba Goddess Garden (078444606) Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)