Label: EVEREDEN SPF20 PROTECTIVE MINERAL FACE CREAM- zinc oxide cream
- NDC Code(s): 72113-108-03
- Packager: Eden Brands Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 18, 2023
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- Official Label (Printer Friendly)
- STATEMENT OF IDENTITY
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
WARNINGS:
- For external use only.
- Do not use on damaged or broken skin.
- Stop use and ask a doctor if rash occurs.
- When using this product keep out of eyes. Rinse with water to remove.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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INSTRUCTIONS FOR USE
DIRECTIONS:
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months of age: ask a doctor
- 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 value of 15 or higher and other sun protection measures including:
-Limit time in the sun, especially from 10am-2pm
-Wear long-sleeved shirts, pants, hats, and sunglasses.
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
Water (Aqua), Caprylic/Capric Triglyceride, Propanediol, Dimethicone, Glycerin, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Tocopheryl Acetate, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Simmondsia Chinensis (Jojoba) Seed Oil, Glycine Soja (Soybean) Oil, Vegetable Oil, Jojoba Esters, Oryza Sativa (Rice) Germ Extract, Oryza Sativa (Rice) Extract, Hydrogenated Vegetable Oil, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Pinnata Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Panthenol, Bisabolol, Glyceryl Stearate, Polyhydroxystearic Acid, Stearyl Alcohol, Sclerotium Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Polyglyceryl-3 Diisostearate, Hydroxyacetophenone, Trisodium Ethylenediamine Disuccinate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EVEREDEN SPF20 PROTECTIVE MINERAL FACE CREAM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72113-108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 115 mg in 1 g Inactive Ingredients Ingredient Name Strength CANDELILLA WAX (UNII: WL0328HX19) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SHEA BUTTER (UNII: K49155WL9Y) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) XANTHAN GUM (UNII: TTV12P4NEE) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) ARGAN OIL (UNII: 4V59G5UW9X) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) WATER (UNII: 059QF0KO0R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB) JOJOBA OIL (UNII: 724GKU717M) SOYBEAN OIL (UNII: 241ATL177A) CORN OIL (UNII: 8470G57WFM) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) RICE GERM (UNII: 7N2B70SFEZ) CUCUMBER (UNII: YY7C30VXJT) PONGAMIA PINNATA SEED (UNII: C2BRV53B1V) BETASIZOFIRAN (UNII: 2X51AD1X3T) LEVOMENOL (UNII: 24WE03BX2T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PANTHENOL (UNII: WV9CM0O67Z) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72113-108-03 1 in 1 CARTON 03/01/2023 1 50 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2023 Labeler - Eden Brands Inc (081062339)
