Label: LA MER THE SOFT MOISTURE FOUNDATION BROAD SPECTRUM SPF 30- octinoxate and titanium dioxide powder
- NDC Code(s): 65966-020-01
- Packager: MAX HUBER RESEARCH LAB 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 August 21, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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Directions
For sunscreen 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 sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- time in the sun, especially from 10 a.m. – 2 p.m.
- long-sleeve shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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Inactive ingredients
TALC • SYNTHETIC FLUORPHLOGOPITE • METHYL METHACRYLATE CROSSPOLYMER • BORON NITRIDE • WATER\AQUA\EAU • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • DIMETHICONE • ALUMINUM HYDROXIDE • DIISOSTEARYL MALATE • ALGAE ( SEAWEED) E X TRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SE ED ME A L • EUCA LY PT US G LOBULUS ( EUCA LY PT US ) L E A F O I L • SODIUM GLUCONAT E • COPPER GLUCONAT E • CALCIUM GLUCONAT E • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • CODIUM TOMENTOSUM EXTRACT • HYDROLYZED CORALLINA OFFICINALIS • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • ACETYL GLUCOSAMINE • ERYNGIUM MARITIMUM EXTRACT • LAMINARIA DIGITATA EXTRACT • GLYCERIN • ACET YL HEXAPEPTIDE-8 • BUT YLENE GLYCOL • HYDROLYZED RICE PROTEIN • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • BARIUM SULFATE • ISOCETYL MYRISTATE • METHICONE • TETRAHEXYLDECYL ASCORBATE • SQUALANE • PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE • POLYSORBATE 80 • CAPRYLYL GLYCOL • SILICA • HYDRATED SILICA • ALUMINUM DISTEARATE • HYDROGEN DIMETHICONE • TOCOPHEROL • FRAGRANCE (PARFUM) • BHT • ALCOHOL DENAT. • POTASSIUM SORBATE • SODIUM DEHYDROACETATE • PHENOXYETHANOL • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77499)] <ILN46686>
- Other information
- PRINCIPAL DISPLAY PANEL - 9.5 g Jar Carton
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INGREDIENTS AND APPEARANCE
LA MER THE SOFT MOISTURE FOUNDATION BROAD SPECTRUM SPF 30
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.1 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6 g in 100 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) BORON NITRIDE (UNII: 2U4T60A6YD) WATER (UNII: 059QF0KO0R) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) NORI (UNII: 477TV3P5UX) SESAME OIL (UNII: QX10HYY4QV) ALFALFA SEED (UNII: 67PHZ58858) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) EUCALYPTUS GUM (UNII: 72T9EZC2VX) SODIUM GLUCONATE (UNII: R6Q3791S76) COPPER GLUCONATE (UNII: RV823G6G67) CALCIUM GLUCONATE (UNII: SQE6VB453K) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) NIACIN (UNII: 2679MF687A) SESAME SEED (UNII: 7Y1255HVXR) LIME PEEL (UNII: 544EQK5Q0W) CODIUM TOMENTOSUM (UNII: B8B45BRU87) WHEY (UNII: 8617Z5FMF6) N-ACETYLGLUCOSAMINE (UNII: V956696549) LAMINARIA DIGITATA (UNII: 15E7C67EE8) GLYCERIN (UNII: PDC6A3C0OX) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) BARIUM SULFATE (UNII: 25BB7EKE2E) ISOCETYL MYRISTATE (UNII: 69AX3BRR5N) METHICONE (20 CST) (UNII: 6777U11MKT) SQUALANE (UNII: GW89575KF9) PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDRATED SILICA (UNII: Y6O7T4G8P9) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) TOCOPHEROL (UNII: R0ZB2556P8) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) ALCOHOL (UNII: 3K9958V90M) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SIGESBECKIA ORIENTALIS FLOWERING TOP (UNII: 6UL878YAR7) DISINTEGRIN AND METALLOPROTEINASE DOMAIN-CONTAINING PROTEIN 11 (UNII: K5Z8ZN42OC) ERYNGIUM MARITIMUM ROOT (UNII: OSE7C1M67D) CORALLINA OFFICINALIS (UNII: 4004498D06) ALMOND (UNII: 3Z252A2K9G) FLUORBENSIDE (UNII: Q449322QX1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65966-020-01 1 in 1 CARTON 06/17/2019 1 9.5 g in 1 JAR; 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 06/17/2019 Labeler - MAX HUBER RESEARCH LAB INC (926708694) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations ASANUMA CORPORATION 715464942 manufacture(65966-020)