TINTED LIP CONDITIONER SPF 15 PLUS LAVENDER

Dosage form: gel
Ingredients: OCTINOXATE 7.5mL in 100mL, OCTISALATE 5.0mL in 100mL
Labeler: MAKEUP ART COSMETICS
NDC Code: 40046-0041

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.

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00%

INACTIVE INGREDIENTS: PETROLATUM [] RICINUS COMMUNIS (CASTOR) SEED OIL [] POLYBUTENE [] MICROCRYSTALLINE WAX\CERA MICROCRISTALLINA\CIRE MICROCRISTALLINE [] ETHYLENE/PROPYLENE/STYRENE COPOLYMER [] HYDROGENATED POLYISOBUTENE [] SILICA [] TOCOPHERYL ACETATE [] SQUALANE [] LECITHIN [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PERSEA GRATISSIMA (AVOCADO) OIL UNSAPONIFIABLES [] LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER  WAX [] ASTROCARYUM MURUMURU SEED BUTTER [] POLYDECENE [] CHOLESTEROL [] TRITICUM VULGARE (WHEAT) GERM OIL [] POLYETHYLENE [] BUTYLENE/ETHYLENE/STYRENE COPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] CALCIUM ALUMINUM BOROSILICATE [] TIN OXIDE [] FLAVOR (AROMA) [] SACCHARIN [] LINALOOL [] GERANIOL [] BHT [] TETRAHEXYLDECYL ASCORBATE []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BLUE 1 LAKE (CI 42090) [] RED 6 (CI 15850) [] RED 7 LAKE (CI 15850) [] RED 28 LAKE (CI 45410) [] RED 30 LAKE (CI 73360) [] RED 33 LAKE (CI 17200) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985)

WARNING: STOP USE IF IRRITATION OCCURS.

PRINCIPAL DISPLAY PANEL:


MAC

TINTED LIP CONDITIONER SPF 15

+ LAVENDER



15 ML/0.5 US FL OZ.



DISTR. BY MAKEUP ART COSMETICS
TORONTO, ONTARIO, CANADA, M5V 1R7



 




TINTED LIP CONDITIONER  SPF 15 PLUS LAVENDER
octinoxate, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0041
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
CASTOR OIL 
MICROCRYSTALLINE WAX 
SILICON DIOXIDE  
POLYISOBUTYLENE (35000 MW) 
LECITHIN, SOYBEAN 
ALMOND OIL 
SHEA BUTTER 
ASTROCARYUM MURUMURU SEED BUTTER 
CHOLESTEROL 
WHEAT GERM OIL 
HIGH DENSITY POLYETHYLENE 
OCTYLTRIETHOXYSILANE 
STANNIC OXIDE  
SACCHARIN 
BUTYLATED HYDROXYTOLUENE 
D&C RED NO. 6 
D&C RED NO. 7 
D&C RED NO. 28 
D&C RED NO. 30 
D&C RED NO. 33 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:40046-0041-11 JAR (JAR) in 1 CARTON
1NDC:40046-0041-215 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2010
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 12/2010
 
MAKEUP ART COSMETICS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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