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
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 January 9, 2023
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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 final M020 07/21/2017 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(64141-025) , label(64141-025) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(64141-025) , label(64141-025) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture(64141-025) , pack(64141-025) , label(64141-025) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(64141-025) , pack(64141-025) , label(64141-025) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(64141-025) , pack(64141-025) , label(64141-025) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(64141-025) , label(64141-025) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(64141-025) , label(64141-025)
