Label: EMME DIANE PURE PROTECTION TINTED ANTIOXIDANT SUNSCREEN- zinc oxide cream
- NDC Code(s): 81377-208-50
- Packager: Emme Diane, Inc.
- 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 January 23, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients:
- Purpose:
-
Uses:
Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings:
-
Directions:
- Apply liberally 15 minutes before sun exposure
- Use a water resistant product if swimming or sweating.
- Reapply at least every 2 hours
- Children under 6 months: 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 10:00 am-2:00 pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
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Inactive Ingredients:
Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer
- Other Information:
- Principal Display Panel – 50 g Bottle Label
-
INGREDIENTS AND APPEARANCE
EMME DIANE PURE PROTECTION TINTED ANTIOXIDANT SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81377-208 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 160 mg in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CERAMIDE NP (UNII: 4370DF050B) Cyclomethicone 6 (UNII: XHK3U310BA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone 20 (UNII: H8YMB5QY0D) Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5) Dimethiconol (2000 CST) (UNII: T74O12AN6Y) Brown Iron Oxide (UNII: 1N032N7MFO) Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N) PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81377-208-50 50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2022 Labeler - Emme Diane, Inc. (116110568) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(81377-208) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(81377-208) , PACK(81377-208)
