Label: 100% PURE GREEN TEA SPF 30 SUNSCREEN- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 52667-012-83 - 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.
Drug Label Information
Updated August 30, 2021
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- Drug Facts
- Purpose:
- Active Ingredient:
- Uses:
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Warnings:
• Skin cancer/Skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging • For external use only • Do not use on damaged or broken skin • When using this product keep out of eyes. Rinse with water to remove • Stop use and ask a doctor if rash occurs • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
- Directions:
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Other Ingredients:
Aqua, Isoamyl Laurate, Caprylic/Capric Triglyceride, Sorbitan Stearate, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Phenethyl Alcohol, Caprylyl Glycol, Glyceryl Isostearate, Xanthan Gum, Cetearyl Glucoside, Polyhydroxystearic Acid, Glycine Soja (Soybean) Oil, Sucrose Cocoate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sesamum Indicum (Sesame) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Persea Gratissima (Avocado) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hip) Fruit Oil, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis (Green Tea) Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Beta-Carotene, Tocopherol (Vitamin E)
- Other Information
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INGREDIENTS AND APPEARANCE
100% PURE GREEN TEA SPF 30 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52667-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 210 mg in 1 mL Inactive Ingredients Ingredient Name Strength SUCROSE COCOATE (UNII: 3H18P0UK73) AVOCADO OIL (UNII: 6VNO72PFC1) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) XANTHAN GUM (UNII: TTV12P4NEE) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SOYBEAN OIL (UNII: 241ATL177A) COCONUT OIL (UNII: Q9L0O73W7L) CUCUMBER FRUIT OIL (UNII: R81Y52NPCT) CARROT (UNII: L56Z1JK48B) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A) PHOSPHATE ION (UNII: NK08V8K8HR) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) RUBUS IDAEUS SEED (UNII: M3CL7US2ZG) WATER (UNII: 059QF0KO0R) ISOAMYL LAURATE (UNII: M1SLX00M3M) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) SESAME OIL (UNII: QX10HYY4QV) OLIVE OIL (UNII: 6UYK2W1W1E) ALMOND OIL (UNII: 66YXD4DKO9) SAFFLOWER SEED (UNII: 8FCL6A31TX) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BETA CAROTENE (UNII: 01YAE03M7J) ALOE VERA LEAF (UNII: ZY81Z83H0X) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52667-012-83 83 mL in 1 TUBE; Type 0: Not a Combination Product 08/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/30/2021 Labeler - Purity Cosmetics (055795259) Establishment Name Address ID/FEI Business Operations Baxter Laboratories Pty. Ltd 740537709 manufacture(52667-012)
