Label: EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15- avobenzone, homosalate, and octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-013-01 - Packager: CLINIQUE LABORATORIES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 11, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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)