Label: 100% PURE EVERYWHERE SUNSCREEN SPF 30- zinc oxide, titanium dioxide stick
- 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.
Updated May 1, 2017
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- Active Ingredients
- KEEP OUT OF REACH OF CHILDREN
- Apply liberally on cleansed skin prior to sun exposure.
- 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 a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Children under 6 months: Ask a doctor.
*Aloe Barbadensis (Aloe Vera) Leaf Oil, *Argania Spinosa Kernal (Argan) Oil, Cera Alba (Beeswax), *Cera Alba (Beeswax), *Calendula Officinalis (Calendula) Flower Extract, *Helianthus Annuus (Sunflower) Seed Oil, *Persea Gratissima (Avocado) Oil, *Ricinus Communis (Castor) Seed Oil, *Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E)
*Certified Organic Ingredients
- Other information
- Questions or comments?
- 100% Pure Everywhere Sunscreen SPF 30 Stick
INGREDIENTS AND APPEARANCE
100% PURE EVERYWHERE SUNSCREEN SPF 30
zinc oxide, titanium dioxide stick
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52667-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 1 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) CASTOR OIL (UNII: D5340Y2I9G) COCOA BUTTER (UNII: 512OYT1CRR) AVOCADO OIL (UNII: 6VNO72PFC1) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ARGAN OIL (UNII: 4V59G5UW9X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52667-004-17 17 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2017 2 NDC:52667-004-70 70 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/09/2014 Labeler - Purity Cosmetics (055795259) Establishment Name Address ID/FEI Business Operations Eco Lips, Inc. 138732727 manufacture(52667-004)