Label: BAREMINERALS COMPLEXION RESCUE DEFENSE RADIANT PROTECTIVE VEIL BROAD SPECTRUM SPF 30 SOFT RADIANCE- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 98132-251-50 - 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 September 5, 2018
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
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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
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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
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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 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
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Inactive Ingredients
water, c9-12 alkane, dimethicone, propanediol, glycerin, peg-32, peg-6, polyglyceryl-4 laurate/succinate, polysorbate 60, camellia japonica flower extract, bupleurum falcatum root extract, undaria pinnatifida extract, hypericum erectum flower/leaf/stem extract, moringa oleifera seed extract, theobroma cacao (cocoa) seed extract, lactobacillus ferment, ceramide np, manganese pca, butylene glycol, succinoglycan, biosaccharide gum-4, bisabolol, allantoin, phytosteryl/octyldodecyl lauroyl glutamate, aminopropyl dimethicone, lauryl betaine, cetyl stearate, isostearyl isostearate, aluminum hydroxide, decyl isostearate, polyquaternium-51, sodium hyaluronate, ascorbyl glucoside, mica, cellulose gum, silica, sodium pca, coco-caprylate/caprate, decyl glucoside, potassium cetyl phosphate, cetyl alcohol, isohexadecane, caprylyl glycol, hexylene glycol, sorbitan oleate, 1,2-hexanediol, sorbitan sesquiisostearate, sodium methyl stearoyl taurate, vp/eicosene copolymer, polyacrylate crosspolymer-6, t-butyl alcohol, polysorbate 80, disodium edta, dimethylacrylamide/sodium acryloyldimethyltaurate crosspolymer, polysilicone-11, disodium phosphate, isostearic acid, sodium citrate, hydrogen dimethicone, sodium acrylate/sodium acryloyldimethyl taurate copolymer, stearic acid, citric acid, triethoxycaprylylsilane, tocopherol, tin oxide, alcohol, fragrance, limonene, linalool, hexyl cinnamal, sodium benzoate, phenoxyethanol. may contain: titanium dioxide, iron oxides.
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
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INGREDIENTS AND APPEARANCE
BAREMINERALS COMPLEXION RESCUE DEFENSE RADIANT PROTECTIVE VEIL BROAD SPECTRUM SPF 30 SOFT RADIANCE
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-251 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 32.8 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 124.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYSORBATE 60 (UNII: CAL22UVI4M) CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) COCOA (UNII: D9108TZ9KG) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) CERAMIDE NP (UNII: 4370DF050B) MANGANESE PIDOLATE (UNII: 3S6I84YKIV) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) LEVOMENOL (UNII: 24WE03BX2T) ALLANTOIN (UNII: 344S277G0Z) PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q) LAURYL BETAINE (UNII: Y4P927Q133) CETYL STEARATE (UNII: 06RI5UQA7L) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DECYL ISOSTEARATE (UNII: NRB038QC02) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) MICA (UNII: V8A1AW0880) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETYL ALCOHOL (UNII: 936JST6JCN) ISOHEXADECANE (UNII: 918X1OUF1E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) POLYSORBATE 80 (UNII: 6OZP39ZG8H) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) ISOSTEARIC ACID (UNII: X33R8U0062) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) STEARIC ACID (UNII: 4ELV7Z65AP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) STANNIC OXIDE (UNII: KM7N50LOS6) ALCOHOL (UNII: 3K9958V90M) LIMONENE, (+/-)- (UNII: 9MC3I34447) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:98132-251-50 1 in 1 CARTON 06/01/2018 1 50 mL 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 06/01/2018 Labeler - Bare Escentuals Beauty, Inc. (087008363)
