Label: REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION OILY- octinoxate, octisalate, and titanium dioxide cream
- NDC Code(s): 49527-022-01
- Packager: CLINIQUE LABORATORIES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
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 • neopentyl glycol diheptanoate • simmondsia chinensis (jojoba) butter • glycerin • petrolatum • octyldodecyl neopentanoate • di-c12-15 alkyl fumarate • dimethicone • hydrogenated lecithin • butylene glycol • hydrogenated polyisobutene • hexyldecyl stearate • sigesbeckia orientalis (st. paul's wort) extract • whey protein\lactis protein\protéine du petit-lait • salvia sclarea (clary) extract • chlorella vulgaris extract • commiphora mukul resin extract • litchi chinensis seed extract • laminaria digitata extract • cladosiphon okamuranus extract • plankton extract • astrocaryum murumuru seed butter • acetyl hexapeptide-8 • lecithin • polyethylene • pentylene glycol • potato starch modified • ergothioneine • glyceryl stearate • caffeine • sorbitol • behenyl alcohol • sodium hyaluronate • methicone • tocopheryl acetate • peg-100 stearate • pentaerythrityl tetraethylhexanoate • caprylyl glycol • c12-16 alcohols • cholesterol • caprylic/capric triglyceride • polysilicone-11 • dextrin • palmitic acid • tetrahexyldecyl ascorbate • hexylene glycol • citric acid • xanthan gum • alumina • ammonium acryloyldimethyltaurate/vp copolymer • sodium hydroxide • disodium edta • potassium sorbate • phenoxyethanol • red 4 (ci 14700) • yellow 5 (ci 19140) • titanium dioxide (ci 77891) • mica [iln39272]
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
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INGREDIENTS AND APPEARANCE
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION OILY
octinoxate, octisalate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-022 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 35 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 17 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) JOJOBA BUTTER (UNII: XIA46H803R) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HEXYLDECYL STEARATE (UNII: OJX2P28Y14) CLARY SAGE (UNII: U3HSK5JC0Q) CHLORELLA VULGARIS (UNII: RYQ4R60M02) GUGGUL (UNII: 34969JX79R) LITCHI CHINENSIS SEED (UNII: 9294024N9Q) LAMINARIA DIGITATA (UNII: 15E7C67EE8) CLADOSIPHON OKAMURANUS (UNII: 2IJE0CH09J) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PENTYLENE GLYCOL (UNII: 50C1307PZG) ERGOTHIONEINE (UNII: BDZ3DQM98W) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CAFFEINE (UNII: 3G6A5W338E) SORBITOL (UNII: 506T60A25R) DOCOSANOL (UNII: 9G1OE216XY) HYALURONATE SODIUM (UNII: YSE9PPT4TH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-100 STEARATE (UNII: YD01N1999R) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) CAPRYLYL GLYCOL (UNII: 00YIU5438U) C12-16 ALCOHOLS (UNII: S4827SZE3L) CHOLESTEROL (UNII: 97C5T2UQ7J) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ICODEXTRIN (UNII: 2NX48Z0A9G) PALMITIC ACID (UNII: 2V16EO95H1) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM OXIDE (UNII: LMI26O6933) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-022-01 1 in 1 CARTON 10/01/2012 1 50 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 10/01/2012 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(49527-022) , pack(49527-022) , label(49527-022)