MARY KAY TIMEWISE MIRACLE SET 3D SAMPLER (COMBO TO OILY SKIN)- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone kit

Mary Kay TimeWise Miracle Set 3D Sampler (Combo to Oily Skin) by

Drug Labeling and Warnings

Mary Kay TimeWise Miracle Set 3D Sampler (Combo to Oily Skin) by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Age Minimize 4-in-1 Cleanser

Age Minimize 3D Day Cream SPF 30 Broad-Spectrum Sunscreen

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 9%

Octisalate 4.5%

Octocrylene 3%

Oxybenzone 4.5%

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

Other information

• protect this product from excessive heat and direct sun
• store above 32° F / 0° C

Inactive ingredients

water/eau, glycerin, dicaprylyl carbonate, dimethicone, ammonium acryloyldimethyltaurate/VP copolymer, cetearyl alcohol, ceteareth-25,  niacinamide, opuntia ficus-indica fruit extract, saccharomyces cerevisiae extract, tocopheryl acetate, oligopeptide-1, resveratrol, sucrose palmitate, bisabolol, silica, disodium ethylene dicocamide PEG-15 disulfate, hydroxypropyl cyclodextrin, glyceryl linoleate, ethoxydiglycol, methyldihydrojasmonate, ethylene brassylate, tetramethyl acetyloctahydronaphthalenes, ethyl linalool, isobutyl methyl tetrahydropyranol,
methylenedioxyphenyl methylpropanal, phenylisohexanol, trimethylbenzenepropanol, methyl benzodioxepinone, triethanolamine, sodium benzoate, disodium EDTA, caprylhydroxamic acid, phenoxyethanol, ethylhexylglycerin, propanediol, caprylyl glycol, iodopropynyl butylcarbamate.

Questions?

Call toll-free 1-800-627-9529

Age Minimize 3D Night Cream

Age Minimize 3D Eye Cream

Principal Display Panel - sample packettes

Mary Kay TimeWise Age Minimize 3D 4-in-1 Cleanser .1 OZ. NET WT. / 3 g

Mary Kay TimeWise Age Minimize 3D Day Cream SPF 30 Broad-Spectrum Sunscreen .06 OZ. NET WT. / 1.7 g / 1,7 g

Mary Kay TimeWise Age Minimize 3D Night Cream .06 OZ. NET WT. / 1.7 g / 1,7 g

Mary Kay TimeWise Age Minimize 3D Eye Cream .01 OZ. NET WT. / 0.5 g / 0,5 g

INGREDIENTS AND APPEARANCE

MARY KAY TIMEWISE MIRACLE SET 3D SAMPLER (COMBO TO OILY SKIN) 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-5607

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-5607-0	1 in 1 CARTON	05/16/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	1.7 g
Part 2	1 PACKET	3 g
Part 3	1 TUBE	1.7 g
Part 4	1 TUBE	0.5 g

Part 1 of 4

TIMEWISE AGE MINIMIZE 3D DAY CREAM SPF 30  BROAD SPECTRUM SUNSCREEN (COMBO TO OILY SKIN)
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-25 (UNII: 8FA93U5T67)
NIACINAMIDE (UNII: 25X51I8RD4)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
RESVERATROL (UNII: Q369O8926L)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
PHENYLISOHEXANOL (UNII: M56178H183)
TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
METHYL BENZODIOXEPINONE (UNII: 0NQ136C313)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1.7 g in 1 PACKET; 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

Part 2 of 4

TIMEWISE AGE MINIMIZE 3D 4-IN-1 CLEANSER (COMBO TO OILY SKIN) 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
INGR	BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ)
INGR	CARNAUBA WAX (UNII: R12CBM0EIZ)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	RESVERATROL (UNII: Q369O8926L)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
INGR	HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
INGR	HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
INGR	ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
INGR	ETHYL LINALOOL (UNII: SF2JS9GF5T)
INGR	TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
INGR	2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
INGR	3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
INGR	PHENYLISOHEXANOL (UNII: M56178H183)
INGR	TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
INGR	METHYL BENZODIOXEPINONE (UNII: 0NQ136C313)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
INGR	MAGNESIUM NITRATE (UNII: 77CBG3UN78)
INGR	METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
INGR	METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
INGR	TALC (UNII: 7SEV7J4R1U)
INGR	D&C RED NO. 30 (UNII: 2S42T2808B)
INGR	ULTRAMARINE BLUE (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 3 of 4

TIMEWISE AGE MINIMIZE 3D NIGHT CREAM (COMBO TO OILY SKIN) 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ISOHEXADECANE (UNII: 918X1OUF1E)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
INGR	ISOCETYL STEARATE (UNII: 3RJ7186O9W)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	CETYL ESTERS WAX (UNII: D072FFP9GU)
INGR	CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	RESVERATROL (UNII: Q369O8926L)
INGR	ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
INGR	SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	DOCOSANOL (UNII: 9G1OE216XY)
INGR	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	POLYSORBATE 80 (UNII: 6OZP39ZG8H)
INGR	HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
INGR	GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
INGR	ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
INGR	TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
INGR	ETHYL LINALOOL (UNII: SF2JS9GF5T)
INGR	2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
INGR	3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
INGR	PHENYLISOHEXANOL (UNII: M56178H183)
INGR	TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
INGR	METHYL BENZODIOXEPINONE (UNII: 0NQ136C313)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 4 of 4

TIMEWISE AGE MINIMIZE 3D EYE CREAM 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	FUCUS VESICULOSUS (UNII: 535G2ABX9M)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	RESVERATROL (UNII: Q369O8926L)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	TRICAPRYLIN (UNII: 6P92858988)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	MICA (UNII: V8A1AW0880)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/16/2018

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-5607)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-5607)

Establishment
Name	Address	ID/FEI	Business Operations
Le Papillon, Ltd.		040070823	pack(51531-5607)