Label: LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20- titanium dioxide lotion
- NDC Code(s): 65966-019-01
- Packager: MAX HUBER RESEARCH LAB 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 August 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- 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:
- 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 • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE • DIMETHICONE • METHYL TRIMETHICONE • DIPHENYLSILOXY PHENYL TRIMETHICONE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • GLYCERIN • BUTYLENE GLYCOL • PENTYLENE GLYCOL • PEG-10 DIMETHICONE • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • CODIUM TOMENTOSUM EXTRACT • ERYNGIUM MARITIMUM EXTRACT • LAMINARIA DIGITATA EXTRACT • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • ACETYL HEXAPEPTIDE-8 • MAGNESIUM SULFATE • ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER • DIMETHICONE CROSSPOLYMER • DISTEARDIMONIUM HECTORITE • LAUROYL LYSINE • ETHYLHEXYLGLYCERIN • POLYHYDROXYSTEARIC ACID • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • CAPRYLYL GLYCOL • LECITHIN • ISOPROPYL MYRISTATE • ISOSTEARIC ACID • ETHYLHEXYL PALMITATE • STEARIC ACID • POLYGLYCERYL-3 POLYRICINOLEATE • ALUMINA • ALUMINUM HYDROXIDE • TOCOPHEROL • TRIETHOXYCAPRYLYLSILANE • FRAGRANCE (PARFUM) • POTASSIUM SORBATE • ALCOHOL DENAT. • DISODIUM EDTA • BHT • LINALOOL • CITRONELLOL • GERANIOL • LIMONENE • HYDROXYCITRONELLAL • PHENOXYETHANOL • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77499)] <ILN44570>
- Other information
- PRINCIPAL DISPLAY PANEL - 12 g x 2 Container Carton
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INGREDIENTS AND APPEARANCE
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.5 g in 100 g Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOSTEARIC ACID (UNII: X33R8U0062) ETHYLHEXYL PALMITATE (UNII: 2865993309) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALCOHOL (UNII: 3K9958V90M) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LINALOOL, (+/-)- (UNII: D81QY6I88E) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) GERANIOL (UNII: L837108USY) LIMONENE, (+)- (UNII: GFD7C86Q1W) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) DIMETHICONE (UNII: 92RU3N3Y1O) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) SESAME OIL (UNII: QX10HYY4QV) ALFALFA SEED (UNII: 67PHZ58858) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) EUCALYPTUS OIL (UNII: 2R04ONI662) 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) LIME PEEL (UNII: 544EQK5Q0W) CODIUM TOMENTOSUM (UNII: B8B45BRU87) ERYNGIUM MARITIMUM WHOLE (UNII: PW58525THK) LAMINARIA DIGITATA (UNII: 15E7C67EE8) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAUROYL LYSINE (UNII: 113171Q70B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65966-019-01 2 in 1 CARTON 07/01/2018 1 12 g in 1 CONTAINER; 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 07/01/2018 Labeler - MAX HUBER RESEARCH LAB INC (926708694) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689049693 manufacture(65966-019)
