Label: MEDIUM FOUNDATION SPF 15- titanium dioxide powder
- NDC Code(s): 98132-880-08, 98132-880-18
- Packager: Bare Escentuals Beauty Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
Titanium Dioxide 25%
- 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
- 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
- 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
Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide
- Questions or Comments?
Call toll free 1-888-795-4747
- INGREDIENTS AND APPEARANCE
MEDIUM FOUNDATION SPF 15
titanium dioxide powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-880 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 25 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:98132-880-08 72 in 1 CASE 1 8 g in 1 JAR 2 NDC:98132-880-18 64 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 01/16/2012 Labeler - Bare Escentuals Beauty Inc. (087008363) Registrant - Ei Inc. (105803274) Establishment Name Address ID/FEI Business Operations Ei Inc. 105803274 manufacture(98132-880) , label(98132-880)