STUDIO FIX FLUID SPF 15 BROAD SPECTRUM- octinoxate and titanium dioxide liquid 
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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STUDIO FIX FLUID SPF 15 BROAD SPECTRUM

Drug Facts

Active IngredientsPurpose
Octinoxate 2.50%Sunscreen
Titanium Dioxide 1.00%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 sunscreen use:

inactive ingredients

water/aqua/eau, cyclopentasiloxane, peg-10 dimethicone, butylene glycol, trimethylsiloxysilicate, dimethicone, magnesium sulfate, laminaria saccharina extract, algae extract, tocopheryl acetate, sodium hyaluronate, tocopherol, lecithin, hydrogenated lecithin, xanthan gum, sorbitan sesquioleate, methoxy amodimethicone/silsesquioxane copolymer, laureth-7, dipropylene glycol, dimethicone/peg-10/15 crosspolymer, dimethicone/peg-10 crosspolymer, peg/ppg-18/18 dimethicone, disteardimonium hectorite, silica, dimethicone crosspolymer, triethoxycaprylylsilane, propylene carbonate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sorbic acid, chloroxylenol, phenoxyethanol [+/- titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln36878>

Other information

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

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / M6JC

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

Principal Display PanelM•A•C

STUDIO FIX FLUID

SPF 15

BROAD SPECTRUM SPF 15

30 ML/1.0 US FL OZ e

STUDIO FIX FLUID SPF 15 BROAD SPECTRUM 
octinoxate and titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0072
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
LAURETH-7 (UNII: Z95S6G8201)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
SORBIC ACID (UNII: X045WJ989B)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0072-11 in 1 CARTON12/01/2005
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 finalM02012/01/2005
Labeler - MAKEUP ART COSMETICS (010597206)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982manufacture(40046-0072)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(40046-0072) , label(40046-0072)

Revised: 8/2023
Document Id: 043cfa0f-5975-17b9-e063-6394a90a31f3
Set id: ff48435d-245a-4037-9afb-caee83c4c415
Version: 9
Effective Time: 20230831
 
MAKEUP ART COSMETICS