STUDIO FIX FLUID BROAD SPECTRUM SPF 15 WITH ENRICHED ANTI-OXIDANT COMPLEX- octinoxate and titanium dioxide lotion 
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 BROAD SPECTRUM SPF 15 WITH ENRICHED ANTI-OXIDANT COMPLEX

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, dimethicone, peg-10 dimethicone, butylene glycol, trimethylsiloxysilicate, magnesium sulfate, dimethicone/peg-10/15 crosspolymer, tocopheryl acetate, sodium hyaluronate, algae extract, olea europaea (olive) leaf extract, oryza sativa (rice) bran extract, laminaria saccharina extract, polygonum cuspidatum root extract, lecithin, hydrogenated lecithin, methoxy amodimethicone/silsesquioxane copolymer, silica, peg/ppg-18/18 dimethicone, dimethicone crosspolymer, laureth-7, triethoxycaprylylsilane, xanthan gum, sorbitan sesquioleate, dipropylene glycol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, chloroxylenol, sorbic acid [+/- titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499), chromium oxide greens (ci 77288)] <iln41302>

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 / MMJC

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

M•A•C

STUDIO FIX FLUID
SPF 15
WITH ENRICHED
ANTI-OXIDANT COMPLEX
BROAD SPECTRUM SPF 15

30 ML/1.0 US FL OZ e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
STUDIO FIX FLUID BROAD SPECTRUM SPF 15 WITH ENRICHED ANTI-OXIDANT COMPLEX 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.02775 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.0111 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
dimethicone (UNII: 92RU3N3Y1O)  
butylene glycol (UNII: 3XUS85K0RA)  
magnesium sulfate (UNII: DE08037SAB)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
olea europaea leaf (UNII: MJ95C3OH47)  
rice bran (UNII: R60QEP13IC)  
saccharina latissima (UNII: 68CMP2MB55)  
polygonum cuspidatum root (UNII: 7TRV45YZF7)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
laureth-7 (UNII: Z95S6G8201)  
triethoxycaprylylsilane (UNII: LDC331P08E)  
xanthan gum (UNII: TTV12P4NEE)  
sorbitan sesquioleate (UNII: 0W8RRI5W5A)  
dipropylene glycol (UNII: E107L85C40)  
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)  
phenoxyethanol (UNII: HIE492ZZ3T)  
chloroxylenol (UNII: 0F32U78V2Q)  
sorbic acid (UNII: X045WJ989B)  
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:40046-0073-11 in 1 CARTON
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/01/2014
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(40046-0073) , REPACK(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(40046-0073) , REPACK(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(40046-0073) , REPACK(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC LLC959338336MANUFACTURE(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(40046-0073) , REPACK(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center (PALC)078364654REPACK(40046-0073) , RELABEL(40046-0073)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(40046-0073)

Revised: 12/2014
Document Id: 1e27f8a9-48f8-4087-9022-f4dfbc09b3b3
Set id: 8bb8db4f-c4a3-4433-a708-70c5d0b7c7b6
Version: 1
Effective Time: 20141202
 
MAKEUP ART COSMETICS