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]

Indications:

Shown to hydrate skin for up to 10 hours.

Provides UVA/UVB protection to help shield skin from the harmful rays of the sun that may cause premature ageing of the skin.

Warnings:

For external use only, not to be swallowed.

Avoid contact with the eyes.

Discontinue use if signs of irritation or rash appear.

Keep out of the reach of children.

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

Overexposure to the sun is dangerous.

Contains Benzophenone-3.

Directions:

Apply liberally to clean face and neck prior to sun exposure.

Reapply frequently to maintain protection.

OTHER INGEDIENTS:

AQUA, ETHYLHEXYL
SALICYLATE, HOMOSALATE, BENZOPHENONE-3, GLYCERETH-26,
DIMETHICONE, GLYCERIN, C12-15
ALKYL BENZOATE, PHENETHYL
BENZOATE, OCTOCRYLENE, BUTYL
METHOXYDIBENZOYLMETHANE,
STYRENE/ACRYLATES COPOLYMER,
TRISILOXANE, POLYESTER-7, BENZYL
ALCOHOL, BUTYLENE GLYCOL,
ETHYLENE/ACRYLIC ACID COPOLYMER,
BETAINE, POLYMETHYLSILSESQUIOXANE, GLYCERYL STEARATE, PEG-100
STEARATE, NEOPENTYL GLYCOL
DIHEPTANOATE, BUTYROSPERMUM
PARKII 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

MK Men

ADVANCED FACIAL HYDRATOR
WITH SPF 30
High Protection UVA

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: 51531-0294
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: 51531-0294-3	1 in 1 CARTON	11/30/2012
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		11/30/2012

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-0294)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-0294)