Label: FAIR FOUNDATION SPF 15- zinc oxide, titanium dioxide powder
- NDC Code(s): 98132-871-18
- Packager: Orveon Global US, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 4, 2023
If you are a consumer or patient please visit this version.
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- 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
- Inactive ingredients
- Questions or Comments?
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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 - Keep out of reach of children.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
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 10/03/2022 1 18 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/03/2022 Labeler - Orveon Global US, LLC (118344494)
