SUNTINTS LIQUID LIP BALM SPF 20- octinoxate, octisalate, avobenzone, homosalate, octocrylene lipstick

SUNTINTS by

Drug Labeling and Warnings

SUNTINTS by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, Len-Ron Manufacturing Division of Aramis Inc., Estee Lauder Inc, Northtec Keystone, Northtec Bristol, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics Ltd., Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics Distribution Centre, ELGC K.K., Estee Lauder N.V., Whitman Laboratories Ltd., Aveda Corporation, Pennsylvania Logistics Center (PALC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] HOMOSALATE 2.90% [] OCTOCRYLENE 2.70%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: OCTYLDODECANOL [] NEOPENTYL GLYCOL DIHEPTANOATE [] ETHYLCELLULOSE [] DIISOSTEARYL MALATE [] BUTYLOCTYL SALICYLATE [] DICAPRYLYL CARBONATE [] TOCOPHERYL ACETATE [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] DEXTRIN PALMITATE [] CALCIUM ALUMINUM BOROSILICATE [] CALCIUM SODIUM BOROSILICATE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] SILICA [] TIN OXIDE [] LINOLEIC ACID [] HYDROGENATED DILINOLEYL ALCOHOL [] VANILLIN [] PHENOXYETHANOL []  [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] 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)]

WARNINGS

WARNING: STOP USE IF IRRITATION OCCURS.

PRINCIPAL DISPLAY PANEL

MAC

SUNTINTS SPF 20

LIQUID BALM

10 ML/ .33 FL OZ LIQ

MAKE UP ART COSMETICS, DIST

NY,NY 10022

INGREDIENTS AND APPEARANCE

SUNTINTS  LIQUID LIP BALM SPF 20
octinoxate, octisalate, avobenzone, homosalate, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.9 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
CALCIUM ALUMINOSILICATE (UNII: 3L00JH8411)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
VANILLIN (UNII: CHI530446X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
COCHINEAL (UNII: TZ8Z31B35M)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0034-1	1 in 1 CARTON
1	NDC: 40046-0034-2	10 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2009

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		959338336	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		943871157	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		244669714	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Centre		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center (PALC)		078364654	repack, relabel