Label: KIDS 50 SPF50- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58479-206-02 - 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 April 17, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask doctor
- When using this product
- Keep out of reach of children
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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.
* Children under 6 months of age: Ask 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 sun, especially from 10a.m. to 2p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Other Information
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Inactive Ingredients
Aloe Barbadensis Leaf Juice*, Aluminum Hydroxide, Butyrospermum Parkii (Shea Butter)*, 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 (Lavender) Oil*, Polyhydroxystearic Acid, Sorbitan Oleate, Stearic Acid, Tocopherol (Vitamin E), Water, Xanthan Gum
* Certified Organic
- Questions or Comments
- Product Label
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INGREDIENTS AND APPEARANCE
KIDS 50 SPF50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58479-206 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 11 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11.25 g in 100 g Inactive Ingredients Ingredient Name Strength CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) LAVENDER OIL (UNII: ZBP1YXW0H8) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) SUNFLOWER OIL (UNII: 3W1JG795YI) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LAVANDIN OIL (UNII: 9RES347CKG) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58479-206-02 100 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2016 Labeler - Crossing cultures LLC dba Goddess Garden (078444606) Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)
