100% PURE GREEN TEA SPF 30 SUNSCREEN- zinc oxide lotion

100% Pure by

Drug Labeling and Warnings

100% Pure by is a Otc medication manufactured, distributed, or labeled by Purity Cosmetics, Baxter Laboratories Pty. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose:

Sunscreen

Active Ingredient:

Zinc Oxide 210mg/g

Uses:

Moisturizes while protecting against sun’s UVA+UVB rays

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:

After cleansing and toning, apply liberally 30 minutes before sun exposure to face, neck, and all other exposed areas. Reapply every 2 hours and after swimming, sweating, or towel drying.

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

Protect this product from excessive heat and direct sun. Store below 30°C/86°F.

Questions or Comments?

Call 1.415.814.9788 or visit www.100PercentPure.com

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

100% Pure Green Tea SPF 30 Sunscreen

2.8 fl oz /83 ml

52667-012-83

INGREDIENTS AND APPEARANCE

100% PURE  GREEN TEA SPF 30 SUNSCREEN
zinc oxide lotion

Product 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)
TOCOPHEROL (UNII: R0ZB2556P8)
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)

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	01/07/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/30/2021	01/07/2025

Labeler - Purity Cosmetics (055795259)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd		740537709	manufacture(52667-012)