STUDIO FIX FLUID BROAD SPECTRUM SPF 15- octinoxate, titanium dioxide emulsion 
MAKEUP ART COSMETICS

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.

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MAC STUDIO FIX FLUID BROAD SPECTRUM SPF 15

Active Ingredients

Octinoxate 3.0%

Titanium Dioxide 1.0%

Purpose

Sunscreen

USE

helps prevent sunburn

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

Inactive Ingredients

WATER\AQUA\EAU,METHYL TRIMETHICONE,DIMETHICONE,TRIMETHYLSILOXYSILICATE,PEG-10 DIMETHICONE,BUTYLENE GLYCOL,ISODODECANE,POLYETHYLENE,CETYL PEG/PPG-10/1 DIMETHICONE,MAGNESIUM SULFATE,ALGAE EXTRACT,LAMINARIA SACCHARINA EXTRACT,SODIUM HYALURONATE,SALIX NIGRA (WILLOW) BARK EXTRACT,TOCOPHERYL ACETATE,CAFFEINE,LECITHIN,HYDROGENATED LECITHIN,DISTEARDIMONIUM HECTORITE,SILICA,XANTHAN GUM,DIMETHICONE CROSSPOLYMER,TRIETHOXYCAPRYLYLSILANE,DIMETHICONE/PEG-10/15 CROSSPOLYMER,METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER,SORBITAN SESQUIOLEATE,SALICYLIC ACID,SODIUM CITRATE,LAURETH-7,METHYLDIHYDROJASMONATE,PROPYLENE CARBONATE,ALUMINA,DIPROPYLENE GLYCOL,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,BHT,PHENOXYETHANOL,SORBIC ACID,CHLOROXYLENOL, [+/- TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499)] <ILN50543>

Other Information

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

PRINCIPAL DISPLAY PANEL

Principal Display PanelMAC
STUDIO FIX
FLUID BROAD SPECTRUM SPF 15
24 HR MATTE FOUNDATION + OIL CONTROL

1.0 FL.OZ.LIQ/30ML e

STUDIO FIX FLUID BROAD SPECTRUM SPF 15 
octinoxate, titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
WATER (UNII: 059QF0KO0R)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
ISODODECANE (UNII: A8289P68Y2)  
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)  
SALIX NIGRA BARK (UNII: QU52J3A5B3)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
SORBIC ACID (UNII: X045WJ989B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
CAFFEINE (UNII: 3G6A5W338E)  
LAURETH-7 (UNII: Z95S6G8201)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0082-11 in 1 CARTON05/12/2023
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 finalM02005/12/2023
Labeler - MAKEUP ART COSMETICS (010597206)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd202952982manufacture(40046-0082)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062manufacture(40046-0082) , pack(40046-0082) , label(40046-0082)

Revised: 5/2023
Document Id: fb59afc1-1dca-f783-e053-6394a90a196b
Set id: fb59afc1-1dc9-f783-e053-6394a90a196b
Version: 1
Effective Time: 20230510
 
MAKEUP ART COSMETICS