Label: MOISTURE SURGE SPF- avobenzone,homosalate,octinoxate,octisalate cream
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NDC Code(s):
49527-084-01,
49527-084-02,
49527-084-03,
49527-084-04, view more49527-084-05
- Packager: CLINIQUE LABORATORIES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USE
- WARNINGS
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DIRECTIONS
For sunscreen use:
• apply liberally and evenly 15 minutes before sun exposurereapply 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 · butylene glycol · ethylhexyl methoxycrylene ·butyloctyl salicylate · dextrin palmitate · polymethylsilsesquioxane ·
glycerin · lactobacillus ferment lysate · aloe barbadensis leaf polysaccharides · sodium hyaluronate · caffeine · sodium
polyaspartate · 7-dehydrocholesterol · caprylyl glycol · acrylates copolymer · sorbitol · dimethicone · polyglyceryl-2 stearate · sucrose ·
saccharide isomerate · hydroxyethyl urea · ppg-8-ceteth-20 · sorbeth-30 tetraisostearate · glyceryl stearate · sorbitan
sesquiisostearate · potassium hydroxide · carbomer · dipropyleneglycol · dehydroxanthan gum · stearyl alcohol · sodium
polyacryloyldimethyl taurate · hexylene glycol · acrylates/beheneth-25 methacrylate copolymer · acrylates/c10-30 alkyl
acrylate crosspolymer · tocopheryl acetate · bht · disodium edta ·sodium citrate · citric acid · potassium sorbate · sodium
benzoate · phenoxyethanol · red 4 (ci 14700) [iln50856] - OTHER INFORMAITON
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOISTURE SURGE SPF
avobenzone,homosalate,octinoxate,octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-084 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 70 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITOL (UNII: 506T60A25R) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) DISODIUM ASPARTATE (UNII: 48MC6MXP9X) SACCHARIDE ISOMERATE (UNII: W8K377W98I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) SUCROSE (UNII: C151H8M554) PPG-8-CETETH-20 (UNII: MAL0SND89Q) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) DIPROPYLENE GLYCOL (UNII: E107L85C40) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CAFFEINE (UNII: 3G6A5W338E) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-084-01 1 in 1 CARTON 11/30/2022 1 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:49527-084-02 1 in 1 CARTON 11/30/2022 2 30 mL in 1 JAR; Type 0: Not a Combination Product 3 NDC:49527-084-03 1 in 1 CARTON 11/30/2022 3 5 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:49527-084-04 1 mL in 1 PACKAGE; Type 0: Not a Combination Product 11/30/2022 12/31/2023 5 NDC:49527-084-05 1 in 1 CARTON 11/07/2022 5 75 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 Drug M020 11/07/2022 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 manufacture(49527-084) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 label(49527-084) , pack(49527-084) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 label(49527-084) , pack(49527-084) Establishment Name Address ID/FEI Business Operations PALC 078364654 label(49527-084) , pack(49527-084)
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