MINERALIZE  MOISTURE SPF 15 FOUNDATION- octinoxate and titanium dioxide liquid 
MAKEUP ART COSMETICS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MINERALIZE MOISTURE SPF 15 FOUNDATION

Drug Facts

Active IngredientsPurpose
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:

inactive ingredients

water\aqua\eau, peg-30 dipolyhydroxystearate, dimethicone, ethylhexyl palmitate, caprylic/capric triglyceride, neopentyl glycol diethylhexanoate, triethylhexanoin, butylene glycol, glycerin, octyldodecyl 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)] <iln 39648>

Other Information

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

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MM2Y

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

M•A•C
MINERALIZE

MOISTURE SPF 15
FOUNDATION
BROAD SPECTRUM SPF 15

30 ML/1.0 US FL OZ e

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
MINERALIZE   MOISTURE SPF 15 FOUNDATION
octinoxate and titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
peg-30 dipolyhydroxystearate (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)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
lysine (UNII: K3Z4F929H6)  
shea butter (UNII: K49155WL9Y)  
haberlea rhodopensis leaf (UNII: N042Q65701)  
tamarind seed (UNII: 6AHP8A7OML)  
beta vulgaris (UNII: 4G174V5051)  
yeast (UNII: 3NY3SM6B8U)  
phytantriol (UNII: 8LVI07A72W)  
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
trehalose (UNII: B8WCK70T7I)  
magnesium chloride (UNII: 02F3473H9O)  
sodium chloride (UNII: 451W47IQ8X)  
potassium chloride (UNII: 660YQ98I10)  
zinc chloride (UNII: 86Q357L16B)  
triethoxycaprylylsilane (UNII: LDC331P08E)  
stannic oxide (UNII: KM7N50LOS6)  
urea (UNII: 8W8T17847W)  
triacetin (UNII: XHX3C3X673)  
caprylyl glycol (UNII: 00YIU5438U)  
hexylene glycol (UNII: KEH0A3F75J)  
edetate disodium (UNII: 7FLD91C86K)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0061-11 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/02/2012
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(40046-0061) , REPACK(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(40046-0061) , RELABEL(40046-0061) , REPACK(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL(40046-0061) , REPACK(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(40046-0061) , RELABEL(40046-0061) , REPACK(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(40046-0061) , RELABEL(40046-0061) , REPACK(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(40046-0061) , RELABEL(40046-0061) , REPACK(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(40046-0061) , RELABEL(40046-0061)
Establishment
NameAddressID/FEIBusiness Operations
MANA PRODUCTS, INC.078870292MANUFACTURE(40046-0061)

Revised: 7/2012
Document Id: d5052f50-2eb8-4113-9295-08b753512025
Set id: fadd572c-05ff-45fb-bd44-cc9b3827d469
Version: 1
Effective Time: 20120723
 
MAKEUP ART COSMETICS