Label: GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide spray
GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58479-042-00, 58479-042-01, 58479-043-00 - 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 December 12, 2016
If you are a consumer or patient please visit this version.
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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. • Should spray white lotion. • Rub in. • Shake well. Should spray white lotion. Rub in. • Do not spray directly into 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 40 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 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*, Polyglyceryl-10 Decaoleate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol (Vitamin E), Water, Xanthan Gum *Certified Organic
- Questions or Comments
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goddess garden
After discovering our daughter was sensitive to synthetic chemicals, we were inspired to create better alternatives using organic, plant-based ingredients. Our sunscreens go on sheer and provide powerful protection that is safe for people and the planet. Paul and Nova, Founders Reef Safe Non-Nano Biodegradable Non-GMO
- Product Label
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INGREDIENTS AND APPEARANCE
GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN SPF 30
titanium dioxide, zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58479-043 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 SAFFLOWER OIL (UNII: 65UEH262IS) LAVANDIN OIL (UNII: 9RES347CKG) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) LAVENDER OIL (UNII: ZBP1YXW0H8) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58479-043-00 227 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 GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN SPF 30
titanium dioxide, zinc oxide aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58479-042 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 SAFFLOWER OIL (UNII: 65UEH262IS) LAVANDIN OIL (UNII: 9RES347CKG) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) LAVENDER OIL (UNII: ZBP1YXW0H8) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58479-042-00 96 g in 1 CAN; Type 0: Not a Combination Product 01/17/2016 2 NDC:58479-042-01 170 g in 1 CAN; 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)