NDC | 98132-871-18, 98132-879-08 |
Set ID | 491a5768-1aad-458e-b4d6-72ea085d1d9f |
Category | HUMAN OTC DRUG LABEL |
Packager | Bare Escentuals Beauty Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
-
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
-
INGREDIENTS AND APPEARANCE
FAIR FOUNDATION SPF 15
zinc oxide, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-879 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 19 g in 100 g 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:98132-879-08 72 in 1 CASE 1 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 01/16/2012 FAIR FOUNDATION SPF 15
zinc oxide, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-871 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 19 g in 100 g 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:98132-871-18 36 in 1 CASE 1 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 10/16/2010 Labeler - Bare Escentuals Beauty Inc. (087008363) Registrant - Ei Inc. (105803274) Establishment Name Address ID/FEI Business Operations Ei Inc. 105803274 manufacture(98132-879) , label(98132-879) , pack(98132-879)