MAC PRO LONGWEAR SPF 20 COMPACT FOUNDATION BROAD SPECTRUM SPF 20- octinoxate and titanium dioxide cream

MAC PRO LONGWEAR SPF 20 COMPACT FOUNDATION BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

MAC PRO LONGWEAR SPF 20 COMPACT FOUNDATION BROAD SPECTRUM SPF 20 by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 2.40%	Sunscreen
Titanium Dioxide 2.30%	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 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

dimethicone, nylon-12, polyethylene, dimethicone crosspolymer, isododecane, dimethicone silylate, tocopheryl acetate, sodium hyaluronate, butyrospermum parkii (shea butter), caryocar brasiliense fruit oil, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, ceramide 2, ethylhexylglycerin, ethylhexyl palmitate, cetyl peg/ppg-10/1 dimethicone, phytosterols, alumina, silica dimethyl silylate, triethoxycaprylylsilane, butylene glycol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499)] <iln40537>

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 - 10 g Jar Carton

MAC

PRO LONGWEAR
SPF 20 COMPACT FOUNDATION
BROAD SPECTRUM SPF 20

NET WT./POIDS NET 10g/0.35 US OZ e

INGREDIENTS AND APPEARANCE

MAC PRO LONGWEAR SPF 20 COMPACT FOUNDATION BROAD SPECTRUM SPF 20 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
dimethicone (UNII: 92RU3N3Y1O)
nylon-12 (UNII: 446U8J075B)
high density polyethylene (UNII: UG00KM4WR7)
isododecane (UNII: A8289P68Y2)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
hyaluronate sodium (UNII: YSE9PPT4TH)
shea butter (UNII: K49155WL9Y)
caryocar brasiliense fruit oil (UNII: WDI9AGC94F)
avocado oil (UNII: 6VNO72PFC1)
olive oil (UNII: 6UYK2W1W1E)
ceramide 2 (UNII: C04977SRJ5)
ethylhexylglycerin (UNII: 147D247K3P)
ethylhexyl palmitate (UNII: 2865993309)
aluminum oxide (UNII: LMI26O6933)
silica dimethyl silylate (UNII: EU2PSP0G0W)
triethoxycaprylylsilane (UNII: LDC331P08E)
butylene glycol (UNII: 3XUS85K0RA)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
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: 40046-0071-1	1 in 1 CARTON
1		10 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2014

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(40046-0071) , REPACK(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(40046-0071) , RELABEL(40046-0071) , REPACK(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(40046-0071) , RELABEL(40046-0071) , REPACK(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(40046-0071) , RELABEL(40046-0071) , REPACK(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(40046-0071) , RELABEL(40046-0071) , REPACK(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(40046-0071)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(40046-0071) , RELABEL(40046-0071)