Label: SPF 30 CONCEALER cream
- NDC Code(s): 81854-001-01
- Packager: Vrea LLC.
- 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 January 9, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WARNINGS AND PRECAUTIONS
- INACTIVE INGREDIENT
- Outer Carton
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SPF 30 CONCEALER
spf 30 concealer creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81854-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.3154 g in 100 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.108665 g in 100 g PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 3.1 g in 100 g PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 2.0705 g in 100 g METHYL METHACRYLATE (UNII: 196OC77688) 1.67 g in 100 g ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 0.21 g in 100 g BORON NITRIDE (UNII: 2U4T60A6YD) 0.185 g in 100 g STEARYL TRIETHOXYSILANE (UNII: 1VN9P25L8H) 0.2499 g in 100 g DUNALIELLA SALINA (UNII: F4O1DKI9A6) 0.0309 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 12.40115 g in 100 g ISODODECANE (UNII: A8289P68Y2) 7.893 g in 100 g DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 0.9288 g in 100 g POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) 0.606 g in 100 g TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 0.2973 g in 100 g ETHYL FERULATE (UNII: 5B8915UELW) 0.2973 g in 100 g HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9) 0.062 g in 100 g PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) 0.005665 g in 100 g PANTOLACTONE, (+/-)- (UNII: IID733HD2M) 0.005665 g in 100 g TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) 0.003 g in 100 g DIMETHICONE 100 (UNII: RO266O364U) 2.0295 g in 100 g LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 2.01 g in 100 g MICA (UNII: V8A1AW0880) 1.665 g in 100 g PROPYLENE CARBONATE (UNII: 8D08K3S51E) 0.258 g in 100 g ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.005665 g in 100 g POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.005665 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 4.117 g in 100 g PROPANEDIOL (UNII: 5965N8W85T) 1.29 g in 100 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.26 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9579 g in 100 g PANTHENOL (UNII: WV9CM0O67Z) 0.3605 g in 100 g WATER (UNII: 059QF0KO0R) 18.795145 g in 100 g Product Characteristics Color brown (Medium Neutral) , brown (Light) , brown (Deep Honey) , brown (Light Neutral) , brown (Rich Neutral) , brown (Fair Neutral) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81854-001-01 1 in 1 CARTON 06/01/2021 1 14 g in 1 TUBE; 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 06/01/2021 Labeler - Vrea LLC. (057455597) Registrant - Vrea LLC. (057455597) Establishment Name Address ID/FEI Business Operations New Look Cosmetics 080801719 manufacture(81854-001)
