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

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

Drug Labeling and Warnings

STUDIO FIX FLUID BROAD SPECTRUM SPF 15 WITH ENRICHED ANTI-OXIDANT COMPLEX by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, ELGC K.K., ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, NORTHTEC LLC, PADC 1, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center (PALC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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:

• apply liberally 15 minutes before sun exposure
• reapply 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, 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

MAC

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

30 ML/1.0 US FL OZ e

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.02775 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0111 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0073-1	1 in 1 CARTON
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/01/2014

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(40046-0073) , REPACK(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0073) , REPACK(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0073) , REPACK(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC LLC		959338336	MANUFACTURE(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0073) , REPACK(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center (PALC)		078364654	REPACK(40046-0073) , RELABEL(40046-0073)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0073)