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.. 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, glycerin, dimethicone, cyclopentasiloxane, butylene glycol, C12-15 alkyl benzoate, phenethyl benzoate, polyester-7, styrene/acrylates copolymer, behenyl alcohol, neopentyl glycol diheptanoate, pentylene glycol, potassium cetyl phosphate, polymethylsilsesquioxane, butyrospermum parkii (shea) butter, squalane, tripeptide-1, panthenol, tocopheryl acetate, allantoin, hexylresorcinol, sodium PCA, centella asiatica meristem cell culture, silybum marianum fruit extract, cestrum latifolium leaf exrtact, calcium ketogluconate, 4-t-butylcyclohexanol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, trisiloxane, arachidyl alcohol, dipropylene glycol dibenzoate, glyceryl stearate, dimethyl capramide, methydihydrojasmonate, ethylene/acrylic acid copolymer, methyl trimethicone, PEG-100 stearate, acrylates/dimethicone copolymer, xanthan gum, arachidyl glucoside, hydrogenated palm glycerides, dimethicone crosspolymer, ethylene brassylate, PPG-15 stearyl ether benzoate, ethyl linalool, polysorbate 60, disodium EDTA, trimethylbenzenepropanol, isobutyl methyl tetrahydropyranol, sorbitan isostearate, cyclohexasiloxane, gamma-undecalactone, phenylisohexanol, sodium benzoate, tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate, ammonium hydroxide, phenoxyethanol, decylene glycol, caprylyl glycol, hydroxypropyl cyclodextrin, hexylene glycol, ethylhexylglycerin, 1,2-hexanediol, iodopropynyl butylcarbamate

Other information

• protect this product from excessive heat and direct sun

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: 51531-2963
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PHENETHYL BENZOATE (UNII: 0C143929GK)
POLYESTER-7 (UNII: 0841698D2F)
DOCOSANOL (UNII: 9G1OE216XY)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
TRISILOXANE (UNII: 9G1ZW13R0G)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
SHEA BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLRESORCINOL (UNII: R9QTB5E82N)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PEG-100 STEARATE (UNII: YD01N1999R)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
CALCIUM 2-KETOGLUCONATE (UNII: 8K5SM7SI6Y)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
XANTHAN GUM (UNII: TTV12P4NEE)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DECYLENE GLYCOL (UNII: S57M60MI88)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
POLYSORBATE 60 (UNII: CAL22UVI4M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
MILK THISTLE (UNII: U946SH95EE)
CESTRUM LATIFOLIUM LEAF (UNII: O2618B6E88)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
PHENYLISOHEXANOL (UNII: M56178H183)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
AMMONIA (UNII: 5138Q19F1X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PREZATIDE (UNII: 39TG2H631E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-2963-7	1 in 1 CARTON	05/16/2016
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	05/16/2016

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-2963)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-2963)