Label: GOLDEN FAIR FOUNDATION SPF 15- titanium dioxide, zinc oxide powder
- NDC Code(s): 98132-923-08
- 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.
Updated January 30, 2013
If you are a consumer or patient please visit this version.
- WARNINGS AND PRECAUTIONS
- Active ingredients:
Titanium dioxide 25%Close
Zinc oxide 17.2%
- helps prevent sunbur
- 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
Directions for sunscree use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen
- 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 of 15 or higher and other sun protection measures including:
- limit time in the sun, especiallyfrom 10 a.m. -2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a 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.Close
- Inactive ingredients
bimuth oxychklride, titanium dioxide, mica, iron oxdes.Close
- Questions or comments?
call toll free 1-888-795-4747Close
- INGREDIENTS AND APPEARANCE
GOLDEN FAIR FOUNDATION SPF 15
titanium dioxide, zinc oxide powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-923 Route of Administration TOPICAL 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 Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide 7.2 g in 100 g Inactive Ingredients Ingredient Name Strength BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BROWN IRON OXIDE (UNII: 1N032N7MFO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:98132-923-08 8 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/15/2012 Labeler - Bare Escentuals Beauty Inc. (087008363) Registrant - Ei Inc. (105803274) Establishment Name Address ID/FEI Business Operations Ei Inc. 105803274 manufacture(98132-923) , label(98132-923)