Label: CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE- titanium dioxide and zinc oxide lotion
- NDC Code(s): 49527-752-01
- Packager: CLINIQUE LABORATORIES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 25, 2024
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- 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•dimethicone•butyloctyl salicylate•polydiethylsiloxane•c12-15 alkyl benzoate•isononyl isononanoate•diethylhexyl succinate•neopentyl glycol diheptanoate•methyl trimethicone•butylene glycol•ethylhexyl methoxycrylene•lauryl peg-9 polydimethylsiloxyethyl dimethicone•silica•dipentaerythrityl tri-polyhydroxystearate•laureth-4•cetyl peg/ppg-10/1 dimethicone•dimethicone/peg-10/15 crosspolymer•dimethicone silylate•hydrolyzed wheat protein/pvp crosspolymer•triethoxycaprylylsilane•dimethicone crosspolymer-3•isostearic acid•caprylyl glycol•polyhydroxystearic acid•dipropylene glycol•phenoxyethanol•iron oxides (ci 77492)•iron oxides (ci 77491) [iln41953]
- Other information
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-752 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 63 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52) LAURETH-4 (UNII: 6HQ855798J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ISOSTEARIC ACID (UNII: X33R8U0062) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIPROPYLENE GLYCOL (UNII: E107L85C40) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-752-01 1 in 1 CARTON 06/01/2016 1 30 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 Drug M020 06/01/2016 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(49527-752) , label(49527-752) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(49527-752) , pack(49527-752) , label(49527-752) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(49527-752) , label(49527-752)