BAREMINERALS COMPLEXION RESCUE DEFENSE RADIANT PROTECTIVE VEIL BROAD SPECTRUM SPF 30 SOFT RADIANCE- titanium dioxide and zinc oxide cream

bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 by

Drug Labeling and Warnings

bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Orveon Global US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium dioxide 3.28%	Sunscreen
Zinc oxide 12.48%	Sunscreen

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

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
• 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-sleeved shirts, pants, hats and sunglasses.
• children under 6 months: Ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun.

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.

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

bareMinerals

COMPLEXION
RESCUE
DEFENSE

RADIANT
PROTECTIVE VEIL

Broad Spectrum SPF 30
Sunscreen

50 ml/1.7 fl. oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS COMPLEXION RESCUE DEFENSE RADIANT PROTECTIVE VEIL BROAD SPECTRUM SPF 30  SOFT RADIANCE
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-000
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 1600 (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)
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)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
DECYL ISOSTEARATE (UNII: NRB038QC02)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MICA (UNII: V8A1AW0880)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
COCOYL CAPRYLOCAPRATE (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)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
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: 98132-000-60	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 Drug	M020	06/01/2018

Labeler - Orveon Global US LLC (118344494)