![EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15 (AVOBENZONE, HOMOSALATE, AND OCTISALATE) CREAM [CLINIQUE LABORATORIES INC]](https://medic.hrt.org//dailymed/images/2a5bbb03-16c2-44ec-86fa-44f8c9ff5b84/even-better-01.jpg)
| NDC | 49527-013-01 |
| Set ID | 2a5bbb03-16c2-44ec-86fa-44f8c9ff5b84 |
| 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 • tricaprylyl citrate • butylene glycol • butyrospermum parkii (shea butter) • yeast extract\faex\extrait de levure • cetearyl alcohol • polymethyl methacrylate • glycerin • sucrose • polyester-8 • saccharomyces cerevisiae extract • peg-100 stearate • dimethicone • glyceryl stearate • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • saccharomyces lysate extract • scutellaria baicalensis root extract • morus bombycis (mulberry) root extract • betula alba (birch) bark extract • oryza sativa (rice) bran extract • chamomilla recutita (matricaria) extract • helianthus annuus (sunflower) seedcake • caffeine • polyglutamic acid • salicylic acid • propylene glycol dicaprate • sodium rna • dipotassium glycyrrhizate • acetyl glucosamine • phospholipids • arginine • sodium hyaluronate • squalane • cetearyl glucoside • ethylhexylglycerin • isohexadecane • tocopheryl acetate • polysorbate 80 • caprylyl glycol • magnesium ascorbyl phosphate • acrylamide/sodium acryloyldimethyltaurate copolymer • xanthan gum • disodium edta • phenoxyethanol [iln38633]
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15
avobenzone, homosalate, and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 g in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.03 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRICAPRYLYL CITRATE (UNII: BXW1GAI4TA) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) SUCROSE (UNII: C151H8M554) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BARLEY (UNII: 5PWM7YLI7R) CUCUMBER (UNII: YY7C30VXJT) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) MORUS INDICA ROOT (UNII: 1VL55O45RF) BETULA PUBESCENS BARK (UNII: 3R504894L9) RICE BRAN (UNII: R60QEP13IC) MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) CAFFEINE (UNII: 3G6A5W338E) SALICYLIC ACID (UNII: O414PZ4LPZ) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) N-ACETYLGLUCOSAMINE (UNII: V956696549) ARGININE (UNII: 94ZLA3W45F) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SQUALANE (UNII: GW89575KF9) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOHEXADECANE (UNII: 918X1OUF1E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-013-01 1 in 1 CARTON 09/01/2011 07/14/2021 1 75 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 09/01/2011 Labeler - CLINIQUE LABORATORIES LLC (044475127) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(49527-013) , REPACK(49527-013) , RELABEL(49527-013) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(49527-013) , RELABEL(49527-013) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(49527-013) , REPACK(49527-013) , RELABEL(49527-013) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 RELABEL(49527-013) , REPACK(49527-013) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(49527-013) , REPACK(49527-013) , RELABEL(49527-013) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(49527-013) , RELABEL(49527-013) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(49527-013) , REPACK(49527-013) , RELABEL(49527-013) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(49527-013) , RELABEL(49527-013) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(49527-013) , RELABEL(49527-013)
