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

Mary Kay TimeWise Age Minimize 3D Day Cream SPF 30 Broad Spectrum Sunscreen (Combo to Oily Skin) by

Drug Labeling and Warnings

Mary Kay TimeWise Age Minimize 3D Day Cream SPF 30 Broad Spectrum Sunscreen (Combo to Oily Skin) by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc., Englewood Lab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

Other information

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

Questions or comments?

Call toll free 1-800-627-9529

Principal Display Panel - 48 g carton

Mary Kay

timewise age minimize 3D day cream

spf 30 broad spectrum suncreen

1.7 OZ. NET WT. / 48 g

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-9005
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	NDC: 51531-9005-7	1 in 1 CARTON	05/16/2018
1		48 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
OTC monograph final	part352	05/16/2018

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-9005)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-9005)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Inc.		080366903	manufacture(51531-9005)