Label: SKIN LONG-WEAR FLUID POWDER FOUNDATION BROAD SPECTRUM SPF 20- ensulizole, titanium dioxide, and zinc oxide liquid
- NDC Code(s): 64141-030-01
- Packager: Bobbi Brown Professional Cosmetics 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 July 14, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally and evenly 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
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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 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
- children under 6 months of age: ask a doctor
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Inactive ingredients
water\aqua\eau ▪ dimethicone ▪ methyl trimethicone ▪ calcium aluminum borosilicate ▪ polymethylsilsesquioxane ▪ trimethylsiloxysilicate ▪ isopentyldiol ▪ hdi/ppg/polycaprolactone crosspolymer ▪ lauryl peg-9 polydimethylsiloxyethyl dimethicone ▪ hydrated silica ▪ peg-10 dimethicone ▪ dimethicone/vinyl dimethicone crosspolymer ▪ whey protein\lactis protein\proteine du petit-lait ▪ isononyl isononanoate ▪ lactobacillus ferment ▪ laminaria digitata extract ▪ sodium hyaluronate ▪ disodium stearoyl glutamate ▪ tocopheryl acetate ▪ serine ▪ aspartic acid ▪ glutamic acid ▪ leucine ▪ alanine ▪ lysine ▪ trisiloxane ▪ arginine ▪ phenylalanine ▪ tyrosine ▪ histidine ▪ isoleucine ▪ threonine ▪ proline ▪ triethyl citrate ▪ valine ▪ lecithin ▪ butylene glycol ▪ caprylyl glycol ▪ triethoxycaprylylsilane ▪ aluminum dimyristate ▪ disteardimonium hectorite ▪ tromethamine ▪ sodium chloride ▪ glycine ▪ magnesium sulfate ▪ silica ▪ disodium edta ▪ bht ▪ phenoxyethanol ▪ [+/- mica ▪ titanium dioxide (ci 77891) ▪ iron oxides (ci 77491) ▪ iron oxides (ci 77492) ▪ iron oxides (ci 77499)] <iln46506>
- Other information
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
SKIN LONG-WEAR FLUID POWDER FOUNDATION BROAD SPECTRUM SPF 20
ensulizole, titanium dioxide, and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 20 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 37 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHYL TRIMETHICONE (UNII: S73ZQI0GXM) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ISOPENTYLDIOL (UNII: 19NOL5474Q) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) HYDRATED SILICA (UNII: Y6O7T4G8P9) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WHEY (UNII: 8617Z5FMF6) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE) LAMINARIA DIGITATA (UNII: 15E7C67EE8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SERINE (UNII: 452VLY9402) ASPARTIC ACID (UNII: 30KYC7MIAI) GLUTAMIC ACID (UNII: 3KX376GY7L) LEUCINE (UNII: GMW67QNF9C) ALANINE (UNII: OF5P57N2ZX) LYSINE (UNII: K3Z4F929H6) TRISILOXANE (UNII: 9G1ZW13R0G) ARGININE (UNII: 94ZLA3W45F) PHENYLALANINE (UNII: 47E5O17Y3R) TYROSINE (UNII: 42HK56048U) HISTIDINE (UNII: 4QD397987E) ISOLEUCINE (UNII: 04Y7590D77) THREONINE (UNII: 2ZD004190S) PROLINE (UNII: 9DLQ4CIU6V) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) VALINE (UNII: HG18B9YRS7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DIMYRISTATE (UNII: J2KA067N9O) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TROMETHAMINE (UNII: 023C2WHX2V) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCINE (UNII: TE7660XO1C) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-030-01 1 in 1 CARTON 10/16/2019 1 40 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 M020 10/16/2019 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(64141-030) , pack(64141-030) , label(64141-030)
