PREP PLUS PRIME BB BEAUTY BALM COMPACT BROAD SPECTRUM SPF 30- octinoxate, octisalate, titanium dioxide, and zinc oxide cream

PREP PLUS PRIME BB BEAUTY BALM COMPACT by

Drug Labeling and Warnings

PREP PLUS PRIME BB BEAUTY BALM COMPACT 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 7.50%	Sunscreen
Octisalate 5.00%	Sunscreen
Titanium Dioxide 9.80%	Sunscreen
Zinc Oxide 6.30%	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 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-sleezed shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

inactive ingredients

octyldodecyl neopentanoate, neopentyl glycol diheptanoate, polyethylene, butyloctyl salicylate, hdi/trimethylol hexyllactone crosspolymer, beeswax\cera alba\cire d'abeille, phenyl trimethicone, c12-15 alkyl benzoate, silica, polybutene, alumina, tocopherol, tocopheryl acetate, glycyrrhiza glabra (licorice) root extract, astrocaryum murumuru seed butter, santalum album seed extract, glycine soja (soybean) oil, elaeis guineensis (palm) oil, euphorbia cerifera (candelilla) wax\candelilla cera\cire de candelilla, hydrogenated cottonseed oil, sodium hyaluronate, squalene, cetyl dimethicone, phytosterols, tocotrienols, ethylhexyl palmitate, triethyl citrate, caprylyl methicone, bis-diglyceryl polyacyladipate-2, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-6 polyricinoleate, caprylyl glycol, butylene glycol, nylon-12, disteardimonium hectorite, triethoxycaprylylsilane, vp/eicosene copolymer, synthetic beeswax, allyl methacrylates crosspolymer, silica dimethyl silylate, lauric acid, isopropyl titanium triisostearate, dipentaerythrityl tri-polyhydroxystearate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499)] <iln39107>

Other information

protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7

PRINCIPAL DISPLAY PANEL - 8g Jar Carton

MAC
PREP+PRIME

BB
BEAUTY BALM
COMPACT SPF 30
BROAD SPECTRUM SPF 30

NET WT. / 8g / 0.28 US OZ e

INGREDIENTS AND APPEARANCE

PREP PLUS PRIME BB BEAUTY BALM COMPACT   BROAD SPECTRUM SPF 30
octinoxate, octisalate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
octyldodecyl neopentanoate (UNII: X8725R883T)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
high density polyethylene (UNII: UG00KM4WR7)
butyloctyl salicylate (UNII: 2EH13UN8D3)
yellow wax (UNII: 2ZA36H0S2V)
phenyl trimethicone (UNII: DR0K5NOJ4R)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
silicon dioxide (UNII: ETJ7Z6XBU4)
aluminum oxide (UNII: LMI26O6933)
tocopherol (UNII: R0ZB2556P8)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
glycyrrhiza glabra (UNII: 2788Z9758H)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
santalum album seed (UNII: 7RZT0U509Y)
soybean oil (UNII: 241ATL177A)
palm oil (UNII: 5QUO05548Z)
candelilla wax (UNII: WL0328HX19)
hydrogenated cottonseed oil (UNII: Z82Y2C65EA)
hyaluronate sodium (UNII: YSE9PPT4TH)
squalene (UNII: 7QWM220FJH)
tocotrienols (UNII: KP2MW85SSQ)
ethylhexyl palmitate (UNII: 2865993309)
triethyl citrate (UNII: 8Z96QXD6UM)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
caprylyl glycol (UNII: 00YIU5438U)
butylene glycol (UNII: 3XUS85K0RA)
nylon-12 (UNII: 446U8J075B)
triethoxycaprylylsilane (UNII: LDC331P08E)
silica dimethyl silylate (UNII: EU2PSP0G0W)
lauric acid (UNII: 1160N9NU9U)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0062-1	1 in 1 CARTON	04/01/2010
1		8 g in 1 JAR; 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	04/01/2010

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0062) , REPACK(40046-0062)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0062)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0062)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0062)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0062)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0062) , REPACK(40046-0062)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0062) , REPACK(40046-0062)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0062)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0062)