Label: MEDIUM BEIGE FOUNDATION SPF 15- zinc oxide, titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 98132-881-08, 98132-881-18 - Packager: Bare Escentuals Beauty 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 February 1, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warnings
- Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging
- This product has been shown only to help prevent sunburn, not skin cancer or early aging
- For External use only
- Do not use on damage or broken skin
- When using this product keep out of eyes. Rinse with water to remove
- Stop use and ask 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
- Apply liberally 15 minutes before sun exposure
- Use a water-resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Sun protection measures. Spending time in the sun increases your risk of skin cancer or early skin aging. To decrease this risk, regularly use a a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long sleeve shirts, pants, hats, and sunglasses
- Children under 6 month: ask a doctor
- Inactive Ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDIUM BEIGE FOUNDATION SPF 15
zinc oxide, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-881 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 21 g in 100 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 12 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) BROWN IRON OXIDE (UNII: 1N032N7MFO) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:98132-881-08 72 in 1 CASE 1 8 g in 1 JAR 2 NDC:98132-881-18 36 in 1 CASE 2 18 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/14/2012 Labeler - Bare Escentuals Beauty Inc. (087008363) Registrant - Ei Inc. (105803274) Establishment Name Address ID/FEI Business Operations Ei Inc. 105803274 manufacture(98132-881) , label(98132-881)
