Label: NO MAKEUP CONCEALER MEDIUM BROAD SPECTRUM SPF 35- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4106-1, 62742-4106-2 - Packager: Allure Labs, 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 December 1, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: Apply along the lower eye contours. genty blend with fingertips and smooth outward. Any excess can also be applied on targeted areas of the face to cover imperfections.
For sunscreen use: apply liberally 15 minutes before sun exposure. use a water resistant sunscreen if swimming or sweating. reapply at atleast every 2 hours. not for use on children.
Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. to decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value 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.
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INACTIVE INGREDIENT
Inactive Ingredients: Cyclopentasiloxane, Water/Aqua/Eau, Dimethicone/PEG-10/15 Crosspolymer, Cyclotetrasiloxane, Dimethicone, Sodium PCA, Polyglyceryl-3 polydimethylsiloxylethyl Dimethicone, glycerin, PPG-12/SMDI Copolymer, Nylon-12, Mica (CI 77019), C12-15 Alkyl Benzoate, Stearic Acid, Tocopheryl Acetate, Glucosyl Hespeidin, Linoleamidopropyl PG-Dimonium Chloride Phosphate, tetrahexyldecyl Ascorbate, Dimethyl MEA, Palmitoyl Hexapeptide, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Palmitoyl Tetrapeptide-7, Ethylhexyl Palmitate, Ethyhexylglycerin, Ceremide 2, N-Hydroxysuccinimide, Hyaluronic Acid, Chrysin, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, PEG/PPG-18/18 Dimethicone, Dimethicone/Vimyl Dimethicone Crosspolymer, Hexyl Laurate, Tribehenin, Triethoxysilylethyl Polydimethylsiloxylethyl Hexyl Dimethicone, Ceteary Olivate, Caprylyl Glycol, Sorbitan Olivate, Hexylene Glycol, Steareth-20, PEG-10 Rapeseed Sterol, Triethoxycaprylylsilane, Silica Dimethyl Silylate, Butylene Glycol, Hydroxypropyl Cyclodextrin, phenoxyethanol, Aluminum Hydroxide, Silica, Iron oxides (CI 77491, CI77492, CI 77499).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NO MAKEUP CONCEALER MEDIUM BROAD SPECTRUM SPF 35
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 59.8 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 48.0 mg in 1 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) GLYCERIN (UNII: PDC6A3C0OX) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) NYLON-12 (UNII: 446U8J075B) MICA (UNII: V8A1AW0880) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLUCOSYL HESPERIDIN (UNII: 432C95B6YE) LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) DEANOL (UNII: 2N6K9DRA24) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CERAMIDE 2 (UNII: C04977SRJ5) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) HYALURONIC ACID (UNII: S270N0TRQY) CHRYSIN (UNII: 3CN01F5ZJ5) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) HEXYL LAURATE (UNII: 4CG9F9W01Q) TRIBEHENIN (UNII: 8OC9U7TQZ0) CETEARYL OLIVATE (UNII: 58B69Q84JO) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN OLIVATE (UNII: MDL271E3GR) HEXYLENE GLYCOL (UNII: KEH0A3F75J) STEARETH-20 (UNII: L0Q8IK9E08) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y) Phenoxyethanol (UNII: HIE492ZZ3T) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4106-2 1 in 1 CARTON 12/01/2017 1 NDC:62742-4106-1 9 g in 1 BOTTLE, WITH APPLICATOR; 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 12/01/2017 Labeler - Allure Labs, Inc (926831603)
