Label: 100% PURE YERBA MATE MIST SPF 30- zinc oxide aerosol, spray
- NDC Code(s): 52667-006-96
- Packager: Purity Cosmetics
- 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
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Do not spray directly onto face. Spray into hands and rub onto your face.
- To ensure adequate sun protection, avoid spreading too thinly when applying.
- Shake well before use.
- Apply liberally 15 minutes before sun exposure.
- 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 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: Consult a physician.
- Other Ingredients
- Other information
- Questions or comments?
- 100% Pure Yerba Mate Mist SPF 30
INGREDIENTS AND APPEARANCE
100% PURE YERBA MATE MIST SPF 30
zinc oxide aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52667-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 120 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCO GLUCOSIDE (UNII: ICS790225B) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SAFFLOWER OIL (UNII: 65UEH262IS) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) BENTONITE (UNII: A3N5ZCN45C) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52667-006-96 96 mL in 1 BOTTLE, SPRAY; 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 05/01/2017 Labeler - Purity Cosmetics (055795259) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(52667-006)