![EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LIQUID [CLINIQUE LABORATORIES INC.]](https://medic.hrt.org//dailymed/images/d4de3c7b-3993-40e5-88a4-f6005ab97531/clinique-01.jpg)
| NDC | 49527-025-01 |
| Set ID | d4de3c7b-3993-40e5-88a4-f6005ab97531 |
| 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
-
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
-
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
-
Inactive ingredients
water\aqua\eau • methyl trimethicone • phenyl trimethicone • dimethicone • triethylhexanoin • butylene glycol • trimethylsiloxysilicate • yeast extract\faex\extrait de levure • peg-10 dimethicone • lauryl peg-9 polydimethylsiloxyethyl dimethicone • alumina • citrus grandis (grapefruit) peel extract • betula alba (birch) bark extract • saccharomyces lysate extract • astrocaryum murumuru seed butter • c12-15 alkyl benzoate • glycerin • sodium myristoyl sarcosinate • acetyl glucosamine • caprylyl methicone • methicone • polyglyceryl-6 polyricinoleate • disteardimonium hectorite • dimethicone crosspolymer-3 • isopropyl titanium triisostearate • lecithin • laureth-7 • tocopheryl acetate • magnesium ascorbyl phosphate • dimethicone/peg-10/15 crosspolymer • dipropylene glycol • sodium chloride • caprylyl glycol • tetrahexyldecyl ascorbate • disodium edta • phenoxyethanol • polyaminopropyl biguanide • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499) • mica • bismuth oxychloride (ci 77163)] [iln39834]
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15
octinoxate, titanium dioxide, and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.06962 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.0412 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.033 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) ALUMINUM OXIDE (UNII: LMI26O6933) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) BETULA PUBESCENS BARK (UNII: 3R504894L9) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D) N-ACETYLGLUCOSAMINE (UNII: V956696549) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) LAURETH-7 (UNII: Z95S6G8201) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLIHEXANIDE (UNII: 322U039GMF) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-025-01 1 in 1 CARTON 09/01/2012 1 30 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 NOT FINAL part352 09/01/2012 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(49527-025) , REPACK(49527-025) , RELABEL(49527-025) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(49527-025) , RELABEL(49527-025) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(49527-025) , REPACK(49527-025) , RELABEL(49527-025) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 RELABEL(49527-025) , REPACK(49527-025) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(49527-025) , REPACK(49527-025) , RELABEL(49527-025) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(49527-025) , REPACK(49527-025) , RELABEL(49527-025) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(49527-025) , RELABEL(49527-025) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(49527-025) , RELABEL(49527-025) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(49527-025) , RELABEL(49527-025)
