Label: SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide lotion
- NDC Code(s): 64141-025-01, 64141-025-02
- Packager: Bobbi Brown Professional Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 25, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
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Directions
For suncreen use:
- apply liberally 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 suncreen 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 • trimethylsiloxysilicate • cetyl peg/ppg-10/1 dimethicone • butylene glycol • glycerin • disteardimonium hectorite • polyglyceryl-3 diisostearate • sodium chloride • laminaria saccharina extract • butyrospermum parkii (shea butter) • fragrance (parfum) • ascorbyl palmitate • tocopherol • dimethicone crosspolymer • methicone • stearic acid • tocopheryl acetate • glyceryl oleate • lecithin • glyceryl stearate • citric acid • aluminum hydroxide • talc • disodium edta • linalool • sodium dehydroacetate • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln44078>
- Other information
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 30 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 16 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) SODIUM CHLORIDE (UNII: 451W47IQ8X) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) SHEA BUTTER (UNII: K49155WL9Y) ASCORBYL PALMITATE (UNII: QN83US2B0N) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) METHICONE (20 CST) (UNII: 6777U11MKT) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL OLEATE (UNII: 4PC054V79P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TALC (UNII: 7SEV7J4R1U) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) LINALOOL, (+/-)- (UNII: D81QY6I88E) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-025-01 1 in 1 CARTON 07/21/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:64141-025-02 1 in 1 CARTON 12/22/2022 2 13 mL in 1 BOTTLE; 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 07/21/2017 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(64141-025) , pack(64141-025) , label(64141-025)