Label: ANTIOXIDANT PRIMER- titanium dioxide and zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 98132-184-09 - Packager: Bare Escentuals Beauty Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 4, 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 INGREDIENT
-
Uses
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.
- Warnings
-
Directions
For sunscreen 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, especially from 10am to 2 pm, wear long-sleeve shirts, pants, hats, and sunglasses.
-
Inactive Ingredients
Cyclopentasiloxane, dimethicone crosspolymer, dimethicone, styrene/acrylates copolymer, hexyl laurate, PEG 10 dimethicone, polyglycerol 4 isostearate, stearic acid, alumina, silica, topcopherol, magnesium silicate, panthenol, glycyrrhiza glaba (licorice) root extract, aloe bardenesis leaf extract, stearyl triethoxysilane, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl retinoate, cyclodextrin. May contain: titanium dioxide and iron oxides.
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
ANTIOXIDANT PRIMER
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-184 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 26 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 62 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) HEXYL LAURATE (UNII: 4CG9F9W01Q) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM SILICATE (UNII: 9B9691B2N9) PANTHENOL (UNII: WV9CM0O67Z) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) ALOE VERA LEAF (UNII: ZY81Z83H0X) STEARYL TRIETHOXYSILANE (UNII: 1VN9P25L8H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) RETINYL RETINOATE (UNII: 5AT5X9J439) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:98132-184-09 1 in 1 CARTON 1 30 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/31/2013 Labeler - Bare Escentuals Beauty Inc. (087008363)
