PREP (PLUS) PRIME BEAUTY BALM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream 
MAKE-UP 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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ACTIVE INGREDIENTS: OCTINOXATE 7.40% [] OCTISALATE 4.00% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10% [] ZINC OXIDE 3.50%

DIRECTIONS:SMOOTH EVENLY ALL OVER THE FACE OR TO THE DESIRED AREA AFTER MOISTURIZER WITH FINGERTIPS, SPONGE OR BRUSH

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:

MAC

PREP + PRIME

BB

BEAUTY BALM

SPF 35



30 ML/1.0 US FL OZ


DIST. BY MAKEUP ART COSMETICS

TORONTO, ONTARIO CANADA M5V 1R7

MAC COSMETICS.COM

FOLDING CARTON

PREP (PLUS) PRIME BEAUTY BALM  SPF 35
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.4 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0036-11 in 1 CARTON
1NDC:40046-0036-230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2010
Labeler - MAKE-UP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
PADC 1110482184manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture

Revised: 5/2010
Document Id: e9ac9caf-34b9-4218-ae0a-fa2182c2898f
Set id: 390daee0-d16b-466a-81df-c30d130f833d
Version: 1
Effective Time: 20100514
 
MAKE-UP ART COSMETICS