Label: CLINIQUE REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY COMBO OILY- octinoxate, octisalate, and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-014-01 - Packager: CLINIQUE LABORATORIES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 16, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY COMBO OILY
octinoxate, octisalate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.5 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.7 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) neopentyl glycol diheptanoate (UNII: 5LKW3C543X) 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) 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:49527-014-01 1 in 1 CARTON 1 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/02/2012 Labeler - CLINIQUE LABORATORIES INC (173047747) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(49527-014) , REPACK(49527-014) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(49527-014) , RELABEL(49527-014) , REPACK(49527-014) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(49527-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(49527-014) , RELABEL(49527-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(49527-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(49527-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(49527-014) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(49527-014) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(49527-014) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(49527-014) , RELABEL(49527-014) , REPACK(49527-014) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(49527-014) , RELABEL(49527-014) , REPACK(49527-014) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(49527-014) , RELABEL(49527-014) , REPACK(49527-014) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(49527-014) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(49527-014) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(49527-014) , RELABEL(49527-014)
