NDC | 65966-019-01 |
Set ID | 66e48ce0-9a5b-4250-b07b-1622b3814c3e |
Category | HUMAN OTC DRUG LABEL |
Packager | MAX HUBER RESEARCH LAB INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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 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 (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) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) 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) 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: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 NOT FINAL part352 07/01/2018 Labeler - MAX HUBER RESEARCH LAB INC (926708694) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(65966-019) , REPACK(65966-019) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(65966-019) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(65966-019) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(65966-019) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(65966-019) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(65966-019) , REPACK(65966-019) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 959338336 MANUFACTURE(65966-019) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(65966-019) , REPACK(65966-019) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(65966-019) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(65966-019) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689049693 MANUFACTURE(65966-019)