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
- Marketing Status: OTC monograph 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 January 10, 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•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 final 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 Estee Lauder Cosmetics Ltd. 204132062 pack(49527-752) , label(49527-752) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture(49527-752) , pack(49527-752) , label(49527-752) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(49527-752) , 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) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(49527-752) , label(49527-752)
