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

MKMen Advanced Facial Hydrator Sunscreen SPF 30 by

Drug Labeling and Warnings

MKMen 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%

Homosalate 5%

Octisalate 5%

Octocrylene 2%

Oxybenzone 4%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
•      use a water resistant sunscreen if swimming or sweating
•      reapply at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
•      limit time in the sun, especially from 10 a.m. - 2 p.m.
•      wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

water, glycereth-26, dimethicone, glycerin, C12-15 alkyl benzoate, phenethyl benzoate, styrene/acrylates copolymer, trisiloxane, 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

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-627-9529

Principal Display Panel - 88 mL carton

mkmen

Advanced Facial Hydrator

Sunscreen Broad Spectrum SPF 30

3 FL. OZ. / 88 mL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-0288
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRISILOXANE (UNII: 9G1ZW13R0G)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PHENETHYL BENZOATE (UNII: 0C143929GK)
POLYESTER-7 (UNII: 0841698D2F)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETAINE (UNII: 3SCV180C9W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-100 STEARATE (UNII: YD01N1999R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
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)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SORBIC ACID (UNII: X045WJ989B)
ALLANTOIN (UNII: 344S277G0Z)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TROLAMINE (UNII: 9O3K93S3TK)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
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: 51531-0288-3	1 in 1 CARTON	05/16/2013
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
OTC monograph final	part352	05/16/2013

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-0288)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-0288)