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

STUDIO FIX FLUID BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

STUDIO FIX FLUID BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, Estee Lauder Companies Inc., Estee Lauder Cosmetics Ltd, Estee Lauder Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 3.0%

Titanium Dioxide 1.0%

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 sunscreen 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. 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

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

MAC
STUDIO FIX
FLUID BROAD SPECTRUM SPF 15
24 HR MATTE FOUNDATION + OIL CONTROL

1.0 FL.OZ.LIQ/30ML e

INGREDIENTS AND APPEARANCE

STUDIO FIX FLUID BROAD SPECTRUM SPF 15 
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0082-1	1 in 1 CARTON	05/12/2023
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	05/12/2023

Labeler - MAKEUP ART COSMETICS (010597206)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd		202952982	manufacture(40046-0082)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	manufacture(40046-0082) , pack(40046-0082) , label(40046-0082)