Label: REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY- octinoxate, octisalate, and titanium dioxide cream
- NDC Code(s): 49527-017-01
- 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 July 27, 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 • simmondsia chinensis (jojoba) butter • petrolatum • polyethylene • glycerin • octyldodecyl neopentanoate • di-c12-15 alkyl fumarate • dimethicone • hydrogenated lecithin • butylene glycol • hydrogenated polyisobutene • hexyldecyl stearate • glyceryl stearate • pentylene glycol • potato starch modified • sigesbeckia orientalis (st. paul's wort) extract • salvia sclarea (clary) extract • chlorella vulgaris extract • commiphora mukul resin extract • litchi chinensis seed extract • laminaria digitata extract • plankton extract • cladosiphon okamuranus extract • whey protein\lactis protein\protéine du petit-lait • astrocaryum murumuru seed butter • sorbitol • caffeine • cholesterol • lecithin • acetyl hexapeptide-8 • sodium hyaluronate • peg-100 stearate • pentaerythrityl tetraethylhexanoate • behenyl alcohol • tocopheryl acetate • caprylyl glycol • c12-16 alcohols • caprylic/capric triglyceride • ergothioneine • polysilicone-11 • methicone • dextrin • palmitic acid • ammonium acryloyldimethyltaurate/vp copolymer • tetrahexyldecyl ascorbate • hexylene glycol • citric acid • potassium sorbate • xanthan gum • alumina • sodium hydroxide • disodium edta • phenoxyethanol • red 4 (ci 14700) • yellow 5 (ci 19140) • titanium dioxide (ci 77891) • mica [iln39282]
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY
octinoxate, octisalate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-017 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) PETROLATUM (UNII: 4T6H12BN9U) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) GLYCERIN (UNII: PDC6A3C0OX) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HEXYLDECYL STEARATE (UNII: OJX2P28Y14) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PENTYLENE GLYCOL (UNII: 50C1307PZG) 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) SORBITOL (UNII: 506T60A25R) CAFFEINE (UNII: 3G6A5W338E) CHOLESTEROL (UNII: 97C5T2UQ7J) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PEG-100 STEARATE (UNII: YD01N1999R) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) DOCOSANOL (UNII: 9G1OE216XY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) C12-16 ALCOHOLS (UNII: S4827SZE3L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ERGOTHIONEINE (UNII: BDZ3DQM98W) ICODEXTRIN (UNII: 2NX48Z0A9G) PALMITIC ACID (UNII: 2V16EO95H1) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) 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:49527-017-01 1 in 1 CARTON 11/24/2020 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 final M020 05/02/2012 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(49527-017) , pack(49527-017) , label(49527-017) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(49527-017) , label(49527-017)
