PREP AND PRIME FORTIFIED SKIN ENHANCER BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream

PREP AND PRIME FORTIFIED SKIN ENHANCER BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

PREP AND PRIME FORTIFIED SKIN ENHANCER BROAD SPECTRUM SPF 35 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
Octinoxate 7.40%	Sunscreen
Octisalate 4.00%	Sunscreen
Zinc Oxide 3.50%	Sunscreen
Oxybenzone 2.50%	Sunscreen
Titanium Dioxide 1.10%	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, butylene glycol, phenyl trimethicone, pentylene glycol, glyceryl stearate, behenyl alcohol, trioctyldodecyl citrate, polymethylsilsesquioxane, octyldodecyl stearoyl stearate, peg-40 stearate, polyglyceryl-10 pentastearate, octyldodecyl neopentanoate, tocopheryl acetate, caffeine, glycyrrhetinic acid, urea, sodium hyaluronate, squalane, hordeum vulgare (barley) extract\extrait d'orge, triticum vulgare (wheat) germ extract, laminaria saccharina extract, glycerin, lecithin, polyglyceryl-6 polyricinoleate, cholesterol, trehalose, sodium pca, oryzanol, ammonium acryloyldimethyltaurate/vp copolymer, sucrose, sodium stearoyl lactylate, xanthan gum, polyquaternium-51, isopropyl titanium triisostearate, triethoxycaprylylsilane, silica, alumina, linoleic acid, stearic acid, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, disodium edta, phenoxyethanol, chlorphenesin, sodium dehydroacetate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), bismuth oxychloride (ci 77163), blue 1 lake (ci 42090), carmine (ci 75470), chromium hydroxide green (ci 77289), ferric ferrocyanide (ci 77510), yellow 5 lake (ci 19140)] <iln37485>

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

PRINCIPAL DISPLAY PANEL - 30 ML Tube Carton

MAC
PREP+PRIME

FORTIFIED
SKIN ENHANCER
SPF 35
BROAD SPECTRUM
SPF 35

30 ML/1.0 US FL OZ e

INGREDIENTS AND APPEARANCE

PREP AND PRIME FORTIFIED SKIN ENHANCER BROAD SPECTRUM SPF 35 
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0436 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02725 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01199 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.03575 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
PEG-40 STEARATE (UNII: ECU18C66Q7)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CAFFEINE (UNII: 3G6A5W338E)
ENOXOLONE (UNII: P540XA09DR)
UREA (UNII: 8W8T17847W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
BARLEY (UNII: 5PWM7YLI7R)
WHEAT (UNII: 4J2I0SN84Y)
GLYCERIN (UNII: PDC6A3C0OX)
CHOLESTEROL (UNII: 97C5T2UQ7J)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
GAMMA ORYZANOL (UNII: SST9XCL51M)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SUCROSE (UNII: C151H8M554)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMINIC ACID (UNII: CID8Z8N95N)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0067-1	1 in 1 CARTON	04/01/2012
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	04/01/2012

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0067) , REPACK(40046-0067)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0067)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0067)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0067)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0067)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0067) , REPACK(40046-0067)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0067) , REPACK(40046-0067)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0067)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0067)