Label: MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25- octinoxate, octisalate, titanium dioxide, and zinc oxide cream
- NDC Code(s): 49527-074-01, 49527-074-02
- Packager: CLINIQUE LABORATORIES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 13, 2023
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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 • c12-15 alkyl benzoate • caprylyl methicone • neopentyl glycol diheptanoate • butylene glycol • pentylene glycol • glycerin • polyglyceryl-10 pentastearate • hydrogenated lecithin • behenyl alcohol • peg-100 stearate • sucrose • laminaria saccharina extract • cucumis sativus (cucumber) fruit extract • aloe barbadensis leaf water • hordeum vulgare (barley) extract\extrait d'orge • caffeine • tocopheryl acetate • isohexadecane • lecithin • sodium stearoyl lactylate • propylene glycol dicaprate • sodium hyaluronate • helianthus annuus (sunflower) seedcake • trehalose • isostearic acid • polyhydroxystearic acid • polysorbate 80 • dimethicone • xanthan gum • polyethylene • acrylamide/sodium acryloyldimethyltaurate copolymer • silica • disodium edta • tetrasodium edta • bht • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499)] [iln45300]
- Other information
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25
octinoxate, octisalate, titanium dioxide, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-074 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 38 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 36 mg in 1 mL Inactive Ingredients Ingredient Name Strength PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) DOCOSANOL (UNII: 9G1OE216XY) PEG-100 STEARATE (UNII: YD01N1999R) SUCROSE (UNII: C151H8M554) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) CUCUMBER (UNII: YY7C30VXJT) ALOE VERA LEAF (UNII: ZY81Z83H0X) BARLEY (UNII: 5PWM7YLI7R) CAFFEINE (UNII: 3G6A5W338E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) TREHALOSE (UNII: B8WCK70T7I) ISOSTEARIC ACID (UNII: X33R8U0062) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) EDETATE SODIUM (UNII: MP1J8420LU) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-074-01 1 in 1 CARTON 10/16/2019 1 40 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49527-074-02 1 mL in 1 TUBE; Type 0: Not a Combination Product 10/16/2019 10/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/16/2019 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 manufacture(49527-074) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 label(49527-074) , pack(49527-074) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(49527-074) , pack(49527-074) , label(49527-074)
