MARY KAY TIMEWISE REPAIR VOLU-FIRM DAY CREAM BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30 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 4%

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, butylene glycol, glycerin, cetearyl alcohol, behenyl alcohol, dicaprylyl carbonate, ammonium acryloyldimethyltaurate/VP copolymer, dimethicone, ceteareth-25, pentylene glycol, tripeptide-1, tocopheryl acetate, hexylresorcinol, sodium PCA, centella asiatica meristem cell culture, silybum marianum fruit extract, cestrum latifolium leaf extract, calcium ketogluconate, 4-t-butylcyclohexanol, disodium ethylene dicocamide PEG-15 disulfate, bisabolol, xanthan gum, methyldihydrojasmonate, ethylene brassylate, ethyl linalool, disodium EDTA, trimethylbenzenepropanol, isobutyl methyl tetrahydropyranol, gamma-undecalactone, phenylisohexanol, sodium benzoate, tetradecyl aminobutyroylvalylaminobutyric urea trifuoroacetate, silica, triethanolamine, citric acid, propanediol, caprylyl glycol, decylene glycol, hydroxypropyl cyclodextrin, phenoxyethanol, hexylene glycol, ethylhexylglycerin, 1,2-hexanediol, 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 repair

volu-firm day cream

sunscreen

broad spectrum

spf 30

1.7 OZ. NET WT. / 48 g

INGREDIENTS AND APPEARANCE

MARY KAY TIMEWISE REPAIR VOLU-FIRM DAY CREAM BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-0549
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	4 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)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DOCOSANOL (UNII: 9G1OE216XY)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARETH-25 (UNII: 8FA93U5T67)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
CALCIUM 2-KETOGLUCONATE (UNII: 8K5SM7SI6Y)
HEXYLRESORCINOL (UNII: R9QTB5E82N)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
TROLAMINE (UNII: 9O3K93S3TK)
LEVOMENOL (UNII: 24WE03BX2T)
DECYLENE GLYCOL (UNII: S57M60MI88)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
MILK THISTLE (UNII: U946SH95EE)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENYLISOHEXANOL (UNII: M56178H183)
PROPANEDIOL (UNII: 5965N8W85T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CESTRUM LATIFOLIUM LEAF (UNII: O2618B6E88)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)
PREZATIDE (UNII: 39TG2H631E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-0549-7	1 in 1 CARTON	05/16/2019
1		48 g in 1 JAR; 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	05/16/2019

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-0549)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-0549)