Label: SUPER BB BEAUTY BALM POWDER SPF 30- titanium dioxide, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 31645-209-01, 31645-209-02 - Packager: PHYSICIANS FORMULA 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 September 28, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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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
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 value of 15 or higher and other sun preotection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive ingredients
Mica, Zinc Stearate, Octyldodecyl Stearoyl Stearate, Dimethicone, Calcium Aluminum Borosilicate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Lauroyl Lysine, Boron Nitride, Triethylhexanoin, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, o-Cymen-5-ol, Silica, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Salix Alba (Willow) Bark Extract, Glycerin, Water/Eau, Lysolecithin, Perilla Ocymoides Seed Oil, Synthetic Fluorphlogopite, Tin Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).
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- Principle Display Panel
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INGREDIENTS AND APPEARANCE
SUPER BB BEAUTY BALM POWDER SPF 30
titanium dioxide, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31645-209 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 15 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MICA (UNII: V8A1AW0880) ZINC STEARATE (UNII: H92E6QA4FV) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) LAUROYL LYSINE (UNII: 113171Q70B) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) SALIX ALBA BARK (UNII: 205MXS71H7) GLYCERIN (UNII: PDC6A3C0OX) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) O-CYMEN-5-OL (UNII: H41B6Q1I9L) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z) WATER (UNII: 059QF0KO0R) STANNIC OXIDE (UNII: KM7N50LOS6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31645-209-02 1 in 1 CARTON 12/27/2012 1 NDC:31645-209-01 8.3 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/27/2012 Labeler - PHYSICIANS FORMULA INC (021261805)
