NDC | 58479-032-00, 58479-032-01, 58479-032-02 |
Set ID | ca29aefd-9662-4d2e-b9ac-fa4b67f7b463 |
Category | HUMAN OTC DRUG LABEL |
Packager | Crossing Cultures LLC dba Goddess Garden |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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
- Questions or Comments
- Package Labeling:
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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)