Label: KIDS NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58479-032-00, 58479-032-01, 58479-032-02 - Packager: Crossing Cultures LLC dba Goddess Garden
- 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 October 12, 2016
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- Drug Facts
- Active Ingredients
- Uses
- Warnings
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Directions
• Hold container 4 to 6 inches from skin to apply. • Spray liberally and spread evenly by hand 15 minutes before sun exposure. • Shake well. 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. • 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. • For use on children less than 6 months of age, consult a doctor.
- Other Information
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Inactive Ingredients
Aloe Barbadensis Leaf Juice*, Aluminum Hydroxide, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride (Coconut Oil), Carthamus Tinctorius (Safflower) Seed Oil*, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Seed Oil*, Lavandula Angustifolia (Lavender) Oil*, Lavandula Hybrida (Lavandin) Oil*, Polygylceryl-10 Decaoleate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol (Vitamin E), Water, Xanthan Gum *Certified Organic
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INGREDIENTS AND APPEARANCE
KIDS NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58479-032 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 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) LAVENDER OIL (UNII: ZBP1YXW0H8) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) LAVANDIN OIL (UNII: 9RES347CKG) POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58479-032-00 96 g in 1 CAN; Type 0: Not a Combination Product 01/17/2016 2 NDC:58479-032-01 170 g in 1 CAN; Type 0: Not a Combination Product 01/17/2016 3 NDC:58479-032-02 227 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/17/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/17/2016 Labeler - Crossing Cultures LLC dba Goddess Garden (078444606) Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)
