FDA.reportPublic FDA data

100% Pure

Manufacturer
Purity Cosmetics | Baxter Laboratories Pty. Ltd
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:45:01

Label at a glance#

Product100% Pure Green Tea SPF 30 Sunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Moisturizes while protecting against sun’s UVA+UVB rays

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 210mg/g

Uses:

INDICATIONS & USAGE SECTION

Moisturizes while protecting against sun’s UVA+UVB rays

Warnings:

WARNINGS SECTION

• 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:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100% Pure Green Tea SPF 30 Sunscreen

2.8 fl oz /83 ml

52667-012-83

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52667-012-832024-12-19C16284748780-1f386c64a-38cf-0266-e053-dadaa90a7c1a100% Pure Green Tea SPF 30 Sunscreen
52667-012-832023-01-30C16284748780-1f386c64a-38cf-0266-e053-dadaa90a7c1a100% Pure Green Tea SPF 30 Sunscreen

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52667-01252667-012-83

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSE COCOATE3H18P0UK73IACT
AVOCADO OIL6VNO72PFC1IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
XANTHAN GUMTTV12P4NEEIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SOYBEAN OIL241ATL177AIACT
COCONUT OILQ9L0O73W7LIACT
TOCOPHEROLR0ZB2556P8IACT
CUCUMBER FRUIT OILR81Y52NPCTIACT
CARROTL56Z1JK48BIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)9M44R3409AIACT
PHOSPHATE IONNK08V8K8HRIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
WATER059QF0KO0RIACT
ISOAMYL LAURATEM1SLX00M3MIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SESAME OILQX10HYY4QVIACT
OLIVE OIL6UYK2W1W1EIACT
ZINC OXIDESOI2LOH54ZACTIM
ALMOND OIL66YXD4DKO9IACT
SAFFLOWER SEED8FCL6A31TXIACT
GLYCERINPDC6A3C0OXIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
BETA CAROTENE01YAE03M7JIACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
29a4d0a2-d9af-c38a-e063-6294a90a1e96ca4d6dd8-4569-2501-e053-2a95a90aac772024-12-19WarningsExact identifier
spl id: 29a4d0a2-d9af-c38a-e063-6294a90a1e96
spl set id: ca4d6dd8-4569-2501-e053-2a95a90aac77

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.