Label: BHSKIN SHEER TINTED ZINC AND TITANIUM SPF 40- titanium dioxide, zinc oxide cream
- NDC Code(s): 83095-203-50
- Packager: Don Mehrabi, M.D. A Professional Medical Corporation
- 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 February 6, 2023
If you are a consumer or patient please visit this version.
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- 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:
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DIRECTIONS:
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- 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 am-2 pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
- INACTIVE INGREDIENTS:
- OTHER INFORMATION:
- Principal Display Panel – 53g Bottle Label
-
INGREDIENTS AND APPEARANCE
BHSKIN SHEER TINTED ZINC AND TITANIUM SPF 40
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83095-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 80 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 38 mg in 1 g Inactive Ingredients Ingredient Name Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) 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) Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX) Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N) PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83095-203-50 53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2023 Labeler - Don Mehrabi, M.D. A Professional Medical Corporation (825145696) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(83095-203) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(83095-203) , PACK(83095-203)
