![EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES, LLC]](https://medic.hrt.org//dailymed/images/2ccf568b-b8ff-414d-b15d-0cab6a57a801/estee-01.jpg)
| NDC | 49527-027-01 |
| Set ID | 2ccf568b-b8ff-414d-b15d-0cab6a57a801 |
| 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•butyloctyl salicylate•nylon-12•octyldodecyl neopentanoate•behenyl alcohol•ascorbyl glucoside•myristyl myristate•cetyl esters•butylene glycol•polyethylene•ammonium acryloyldimethyltaurate/vp copolymer•saccharomyces cerevisiae extract•yeast extract\faex\extrait de levure•betula alba (birch) bark extract•cucumis sativus (cucumber) fruit extract•scutellaria baicalensis root extract•pyrus malus (apple) fruit extract•trametes versicolor extract•triticum vulgare (wheat) bran extract•saccharomyces lysate extract•punica granatum (pomegranate) fruit juice•olea europaea (olive) fruit extract•curcuma longa (turmeric) root extract•oryza sativa (rice) bran extract•citrus grandis (grapefruit) peel extract•peg-6•cholesterol•dimethicone•glyceryl stearate•peg-100 stearate•glycerin•di-ppg-2 myreth-10 adipate•steareth-21•caffeine sodium rna•cellulose•acetyl glucosamine•tromethamine•sucrose•myristyl laurate•di-c12-18 alkyl dimonium chloride•salicylic acid•sodium hyaluronate•tocopheryl acetate•trisiloxane•linoleic acid•caprylyl glycol•myristyl alcohol•sodium sulfite•sodium metabisulfite•magnesium ascorbyl phosphate•betaine•trehalose•hexylene glycol•dipotassium glycyrrhizate•lauryl peg-9 polydimethylsiloxyethyl dimethicone•sodium hydroxide•disodium edta•phenoxyethanol [iln46501]
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
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INGREDIENTS AND APPEARANCE
EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20
avobenzone, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-082 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 28 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NYLON-12 (UNII: 446U8J075B) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) CETYL ESTERS WAX (UNII: D072FFP9GU) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) BETULA PUBESCENS BARK (UNII: 3R504894L9) CUCUMBER (UNII: YY7C30VXJT) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) APPLE (UNII: B423VGH5S9) WHEAT BRAN (UNII: 6L966A1IMR) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) POMEGRANATE JUICE (UNII: 99S671U9KB) BLACK OLIVE (UNII: 2M6QWV94OC) TURMERIC (UNII: 856YO1Z64F) RICE BRAN (UNII: R60QEP13IC) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) CHOLESTEROL (UNII: 97C5T2UQ7J) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) STEARETH-21 (UNII: 53J3F32P58) CAFFEINE (UNII: 3G6A5W338E) POWDERED CELLULOSE (UNII: SMD1X3XO9M) N-ACETYLGLUCOSAMINE (UNII: V956696549) TROMETHAMINE (UNII: 023C2WHX2V) SUCROSE (UNII: C151H8M554) SALICYLIC ACID (UNII: O414PZ4LPZ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRISILOXANE (UNII: 9G1ZW13R0G) LINOLEIC ACID (UNII: 9KJL21T0QJ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM SULFITE (UNII: VTK01UQK3G) SODIUM METABISULFITE (UNII: 4VON5FNS3C) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) BETAINE (UNII: 3SCV180C9W) TREHALOSE (UNII: B8WCK70T7I) HEXYLENE GLYCOL (UNII: KEH0A3F75J) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) MYRISTYL ALCOHOL (UNII: V42034O9PU) N-DIALKYL METHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 00MFZ4H95Z) MYRISTYL LAURATE (UNII: 58U0NZN2BT) SODIUM RICINOLEATE (UNII: OOO64813BX) DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ) TRAMETES VERSICOLOR STRAIN CM-101 (UNII: 26BE3YVD39) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) DOCOSANOL (UNII: 9G1OE216XY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-082-01 1 in 1 CARTON 06/01/2012 1 50 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 06/01/2012 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(49527-082) , REPACK(49527-082) , RELABEL(49527-082) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(49527-082) , RELABEL(49527-082) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(49527-082) , REPACK(49527-082) , RELABEL(49527-082) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 REPACK(49527-082) , RELABEL(49527-082) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(49527-082) , REPACK(49527-082) , RELABEL(49527-082) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(49527-082) , RELABEL(49527-082) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(49527-082) , RELABEL(49527-082) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(49527-082) , REPACK(49527-082) , RELABEL(49527-082) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(49527-082) , RELABEL(49527-082)
