MAC MINERALIZE MOISTURE SPF 15 BROAD SPECTRUM FOUNDATION- octinoxate and titanium dioxide liquid

MAC MINERALIZE MOISTURE SPF 15 BROAD SPECTRUM FOUNDATION by

Drug Labeling and Warnings

MAC MINERALIZE MOISTURE SPF 15 BROAD SPECTRUM FOUNDATION 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
Titanium Dioxide 2.00%	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, peg-30 dipolyhydroxystearate, dimethicone, ethylhexyl palmitate, caprylic/capric triglyceride, neopentyl glycol diethylhexanoate, triethylhexanoin, butylene glycol, glycerin, octydodecyl neopentanoate, squalane, silica, tocopherol, tocopheryl acetate, sodium hyaluronate, lysine, butyrospermum parkii (shea butter), haberlea rhodopensis leaf extract, tamarindus indica seed extract, beta vulgaris (beet) root extract\beta vulgaris\extrait de racine de betterave, yeast extract\faex\extrait de levure, phytantriol, octyldodecyl pca, sodium pca, trehalose, magnesium chloride, sodium chloride, potassium chloride, zinc chloride, simethicone, synthetic fluorphlogopite, disteardimonium hectorite, polyglyceryl-3 beeswax, triethoxycaprylylsilane, dimethicone crosspolymer-3, tin oxide, urea, triacetin, polyquaternium-51, caprylyl glycol, hexylene glycol, hydrogenated lecithin, disodium edta, phenoxyethanol, sodium dehydroacetate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499)] <iln39648>

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 Bottle Carton

MAC
MINERALIZE

MOISTURE SPF 15
FOUNDATION
BROAD SPECTRUM SPF 15

30 ML/1.0 US FL OZ e

INGREDIENTS AND APPEARANCE

MAC MINERALIZE MOISTURE SPF 15 BROAD SPECTRUM FOUNDATION 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0835 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0217 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
SQUALANE (UNII: GW89575KF9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LYSINE (UNII: K3Z4F929H6)
SHEA BUTTER (UNII: K49155WL9Y)
BEET (UNII: N487KM8COK)
PHYTANTRIOL (UNII: 8LVI07A72W)
SODIUM (UNII: 9NEZ333N27)
PIDOLIC ACID (UNII: SZB83O1W42)
TREHALOSE (UNII: B8WCK70T7I)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STANNIC OXIDE (UNII: KM7N50LOS6)
UREA (UNII: 8W8T17847W)
TRIACETIN (UNII: XHX3C3X673)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 40046-0079-1	1 in 1 CARTON	07/02/2012
1		30 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	07/02/2012

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0079) , REPACK(40046-0079)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0079)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0079)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0079)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0079)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0079) , REPACK(40046-0079)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0079) , REPACK(40046-0079)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0079)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0079)