MK MEN ADVANCED FACIAL HYDRATOR SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

MK Men Advanced Facial Hydrator Sunscreen SPF 30 by

Drug Labeling and Warnings

MK Men Advanced Facial Hydrator Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

AVOBENZONE (2% W/W)

HOMOSALATE (5% W/W)

OCTISALATE (5% W/W)

OCTOCRYLENE (2% W/W)

OXYBENZONE (4% W/W)

Indications:

Broad spectrum UVA/UVB protection.

Filters certain of the sun's harmful UV rays to help prevent sunburn.

Warnings:

For external use only, not to be swallowed.

Avoid contact with the eyes.

If contact occurs, rinse thoroughly with water.

Discontinue use if skin irritation develops or increases.

If irritation persists, consult a doctor.

Contains Oxybenzone.

Keep out of the reach of children.

Do not stay too long in the sun, even while using a sunscreen product.

Directions:

Apply liberally after using cleanser and prior to sun exposure.

For SPF protection, reapply frequently and as necessary.

OTHER INGEDIENTS:

WATER/EAU, TRISILOXANE,
GLYCERETH-26, GLYCERIN, C12-15 ALKYL BENZOATE, PHENETHYL BENZOATE, STYRENE/
ACRYLATES COPOLYMER, POLYESTER-7,
BENZYL ALCOHOL, BUTYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, ETHYLENE/
ACRYLIC ACID COPOLYMER, BETAINE, GLYCERYL STEARATE, DIMETHICONE, PEG-100
STEARATE, NEOPENTYL GLYCOL DIHEPTANOATE, BUTYROSPERMUM PARKII (SHEA)
BUTTER, SQUALANE, DIPROPYLENE GLYCOL
DIBENZOATE, PANTHENOL, ALLANTOIN,
TOCOPHERYL ACETATE, ARACHIDYL ALCOHOL, METHYL TRIMETHICONE, DIMETHYL
CAPRAMIDE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE
COPOLYMER, ACRYLATES/DIMETHICONE
COPOLYMER, PENTYLENE GLYCOL,
BEHENYL ALCOHOL, POTASSIUM CETYL
PHOSPHATE, HYDROGENATED PALM
GLYCERIDES, ARACHIDYL GLUCOSIDE,
PPG-15 STEARYL ETHER BENZOATE, C9-15
ALKYL PHOSPHATE, POLYSORBATE 60,
HYDROGENATED LECITHIN, SODIUM PCA,
LAURAMINE OXIDE, DISODIUM EDTA,
TRIETHANOLAMINE, XANTHAN GUM,
SORBITAN ISOSTEARATE, SORBIC ACID,
METHYLPARABEN, CAPRYLYL GLYCOL,
PHENOXYETHANOL, METHYLDIHYDROJASMONATE, ETHYLENE BRASSYLATE, ETHYL
LINALOOL, TRIMETHYLBENZENEPROPANOL,
ISOBUTYL METHYL TETRAHYDROPYRANOL,
AMMONIUM HYDROXIDE, GAMMA-UNDECALACTONE, PHENYLISOHEXANOL, BHT.

Principal Display Panel - 88 mL Carton

MK Men

ADVANCED FACIAL HYDRATOR
SUNSCREEN SPF 30
HYDRATANT VISAGE
FPS 30 INTENSIF
LOCIÓN FACIAL HIDRATANTE
INTENSIVA FPS 30
LOTION / LOCIÓN
DIN 02395630

3 FL. OZ. / 88 mL

INGREDIENTS AND APPEARANCE

MK MEN ADVANCED FACIAL HYDRATOR SUNSCREEN SPF 30 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-0291
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERETH-26 (UNII: NNE56F2N14)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PHENETHYL BENZOATE (UNII: 0C143929GK)
TRISILOXANE (UNII: 9G1ZW13R0G)
POLYESTER-7 (UNII: 0841698D2F)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETAINE (UNII: 3SCV180C9W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PEG-100 STEARATE (UNII: YD01N1999R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
SQUALANE (UNII: GW89575KF9)
SHEA BUTTER (UNII: K49155WL9Y)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DOCOSANOL (UNII: 9G1OE216XY)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBIC ACID (UNII: X045WJ989B)
ALLANTOIN (UNII: 344S277G0Z)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TROLAMINE (UNII: 9O3K93S3TK)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
AMMONIA (UNII: 5138Q19F1X)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
PHENYLISOHEXANOL (UNII: M56178H183)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-0291-3	1 in 1 CARTON	12/05/2012
1		88 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		12/05/2012

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-0291)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-0291)