STUDIO MOISTURE FIX BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octisalate, and octocrylene lotion

STUDIO MOISTURE FIX BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

STUDIO MOISTURE FIX BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, 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, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone 1.00%	Sunscreen
Octinoxate 3.50%	Sunscreen
Octisalate 3.50%	Sunscreen
Octocrylene 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, dimethicone, c12-15 alkyl benzoate, butylene glycol, silica, isononyl isononanoate, glycerin, tocopheryl acetate, sodium hyaluronate, squalane, triticum vulgare (wheat) germ extract, hordeum vulgare (barley) extract\extrait d'orge, astrocaryum murumuru seed butter, polygonum cuspidatum root extract, poria cocos sclerotium extract, saccharomyces lysate extract, yeast extract\faex\extrait de levure, cholesterol, caffeine, sodium rna, phytosphingosine, sucrose, thermus thermophillus ferment, isohexadecane, laureth-4, magnesium ascorbyl phosphate, polysorbate 20, polysorbate 80, steareth-21, pvp, cetrimonium chloride, cetyl esters, polyethylene, caprylyl glycol, hexylene glycol, propylene glycol dicaprate, linoleic acid, glyceryl stearate, peg-100 stearate, ammonium acryloyldimethyltaurate/vp copolymer, acrylamide/sodium acryloyldimethyltaurate copolymer, fragrance (parfum), disodium edta, sodium citrate, phenoxyethanol, chlorphenesin <iln38687>

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 / M6HH

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton

MAC

STUDIO
MOISTURE FIX
SPF 15
BROAD SPECTRUM
SPF 15

50 ML/1.7 US FL OZ e

INGREDIENTS AND APPEARANCE

STUDIO MOISTURE FIX BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.010105 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.035545 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.035545 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.010105 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
butylene glycol (UNII: 3XUS85K0RA)
silicon dioxide (UNII: ETJ7Z6XBU4)
isononyl isononanoate (UNII: S4V5BS6GCX)
glycerin (UNII: PDC6A3C0OX)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
hyaluronate sodium (UNII: YSE9PPT4TH)
squalane (UNII: GW89575KF9)
wheat germ (UNII: YR3G369F5A)
barley (UNII: 5PWM7YLI7R)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
reynoutria japonica root (UNII: 7TRV45YZF7)
saccharomyces lysate (UNII: R85W246Z1C)
yeast, unspecified (UNII: 3NY3SM6B8U)
cholesterol (UNII: 97C5T2UQ7J)
caffeine (UNII: 3G6A5W338E)
phytosphingosine (UNII: GIN46U9Q2Q)
sucrose (UNII: C151H8M554)
thermus thermophilus lysate (UNII: 775R692494)
isohexadecane (UNII: 918X1OUF1E)
laureth-4 (UNII: 6HQ855798J)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
polysorbate 20 (UNII: 7T1F30V5YH)
polysorbate 80 (UNII: 6OZP39ZG8H)
steareth-21 (UNII: 53J3F32P58)
povidone, unspecified (UNII: FZ989GH94E)
cetrimonium chloride (UNII: UC9PE95IBP)
cetyl esters wax (UNII: D072FFP9GU)
high density polyethylene (UNII: UG00KM4WR7)
caprylyl glycol (UNII: 00YIU5438U)
hexylene glycol (UNII: KEH0A3F75J)
propylene glycol dicaprate (UNII: U783H9JHWY)
linoleic acid (UNII: 9KJL21T0QJ)
glyceryl monostearate (UNII: 230OU9XXE4)
peg-100 stearate (UNII: YD01N1999R)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
edetate disodium (UNII: 7FLD91C86K)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0076-1	00 in 1 CARTON	09/01/2012
1		50 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 NOT FINAL	part352	09/01/2012

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0076) , REPACK(40046-0076)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0076)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0076)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0076)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0076)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0076) , REPACK(40046-0076)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0076) , REPACK(40046-0076)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0076)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0076)