NDC | 49527-056-01 |
Set ID | 756cb656-2f79-4e7f-b4b3-18d6e8930921 |
Category | HUMAN OTC DRUG LABEL |
Packager | CLINIQUE LABORATORIES LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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:
- 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 • methyl trimethicone • phenyl trimethicone • triethylhexanoin • dimethicone • butylene glycol • trimethylsiloxysilicate • peg-10 dimethicone • lauryl peg-9 polydimethylsiloxyethyl dimethicone • aluminum hydroxide • c12-15 alkyl benzoate • glycerin • citrus grandis (grapefruit) peel extract • betula alba (birch) bark extract • saccharomyces lysate extract • camellia sinensis leaf extract • astrocaryum murumuru seed butter • yeast extract\faex\extrait de levure • salicylic acid • sodium hyaluronate • caprylyl glycol • jojoba esters • sodium myristoyl sarcosinate • sodium chloride • tocopheryl acetate • acetyl glucosamine • caprylyl methicone • polyglyceryl-6 polyricinoleate • methicone • dimethicone crosspolymer-3 • lecithin • magnesium ascorbyl phosphate • tetrahexyldecyl ascorbate • disteardimonium hectorite • isopropyl titanium triisostearate • laureth-7 • dipropylene glycol • dimethicone/peg-10/15 crosspolymer • disodium edta • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • bismuth oxychloride (ci 77163) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499) [iln43351]
- Other information
- PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton
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INGREDIENTS AND APPEARANCE
EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15
octinoxate, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0675 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.04275 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.03375 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) BETULA PUBESCENS BARK (UNII: 3R504894L9) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) SALICYLIC ACID (UNII: O414PZ4LPZ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) N-ACETYLGLUCOSAMINE (UNII: V956696549) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) METHICONE (20 CST) (UNII: 6777U11MKT) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) LAURETH-7 (UNII: Z95S6G8201) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) 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:49527-056-01 1 in 1 CARTON 03/20/2017 1 30 mL 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 NOT FINAL part352 03/20/2017 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(49527-056) , RELABEL(49527-056) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(49527-056) , REPACK(49527-056) , RELABEL(49527-056) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(49527-056) , REPACK(49527-056) , RELABEL(49527-056) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 RELABEL(49527-056) , REPACK(49527-056) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(49527-056) , REPACK(49527-056) , RELABEL(49527-056) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(49527-056) , RELABEL(49527-056) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(49527-056) , RELABEL(49527-056) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(49527-056) , REPACK(49527-056) , RELABEL(49527-056) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(49527-056) , RELABEL(49527-056)