CLINIQUE FIT WORKOUT MAKEUP BROAD SPECTRUM SPF 40- octinoxate, octisalate, and titanium dioxide cream 
CLINIQUE LABORATORIES LLC

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.

----------

CLINIQUE FIT WORKOUT MAKEUP BROAD SPECTRUM SPF 40

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 2.0%
Titanium Dioxide 1.6%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscren use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spening time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary 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

Inactive ingredients

water\aqua\eau • methyl trimethicone • alcohol • ethylhexyl palmitate • peg-9 polydimethylsiloxyethyl dimethicone • propanediol • glycerin • glyceryl caprylate • peg-3 dimethicone • dimethicone • tocopheryl acetate • lecithin • triethoxycaprylylsilane • stearyl glycyrrhetinate • sorbitan sesquiisostearate • sodium hyaluronate • pyridoxine hcl • palmitoyl tetrapeptide-7 • dipeptide-2 • stearic acid • hesperidin methyl chalcone • sodium chloride • aluminum hydroxide • steareth-20 • silica • sodium citrate • phenoxyethanol • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • titanium dioxide (ci 77891)] [iln43830]

Other information

proctect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

CLINIQUEFIT

BE MATTE
ON THE MAT.

WORKOUT
MAKEUP
BROAD
SPECTRUM
SPF 40

C

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
CLINIQUE FIT WORKOUT MAKEUP BROAD SPECTRUM SPF 40 
octinoxate, octisalate, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0218 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.01744 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARETH-20 (UNII: L0Q8IK9E08)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-055-011 in 1 CARTON02/15/201706/30/2021
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/15/201706/30/2021
Labeler - CLINIQUE LABORATORIES LLC (044475127)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
J.O. COSMETICS691704652MANUFACTURE(49527-055)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277MANUFACTURE(49527-055) , PACK(49527-055) , LABEL(49527-055)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(49527-055) , PACK(49527-055) , LABEL(49527-055)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062PACK(49527-055) , LABEL(49527-055)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(49527-055) , PACK(49527-055) , LABEL(49527-055)
Establishment
NameAddressID/FEIBusiness Operations
Northtec LLC943871157PACK(49527-055) , LABEL(49527-055)
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(49527-055) , PACK(49527-055) , LABEL(49527-055)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774PACK(49527-055) , LABEL(49527-055)

Revised: 7/2021
 
CLINIQUE LABORATORIES LLC