MARY KAY TIMEWISE DAY SOLUTION SPF 35- avobenzone, homosalate, octisalate, octocrylene, oxybenzone solution

Mary Kay TimeWise Day Solution SPF 35 by

Drug Labeling and Warnings

Mary Kay TimeWise Day Solution SPF 35 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 10%

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, dimethicone, butylene glycol, styrene/acrylates copolymer, C12-15 alkyl

benzoate, dicaprylyl carbonate, glycerin, ceteareth-25, dimethicone crosspolymer,

magnesium aluminum silicate, acetyl dipeptide-1 cetyl ester, plankton extract,

hydrolyzed algin, pentylene glycol, tocopheryl acetate, crithmum maritimum extract,

ascorbic acid, hydrogenated lecithin, hydroxyethylcellulose, dipropylene glycol

dibenzoate, acrylates/C12-22 alkyl methacrylate copolymer, disodium ethylene

dicocamide PEG-15 disulfate, sorbic acid, caprylyl glycol, PPG-15 stearyl ether benzoate,

propylene glycol, xanthan gum, cyclopentasiloxane, PEG-75, PEG-150, PEG-8 cetyl

dimethicone, PEG-4 laurate, laureth-3, disodium EDTA, ammonium hydroxide,

iodopropynyl butylcarbamate, phenoxyethanol

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 - 29 mL carton

Mary Kay

timewise

day solution sunscreen

broad spectrum spf 35

1 FL. OZ. / 29 mL

INGREDIENTS AND APPEARANCE

MARY KAY TIMEWISE DAY SOLUTION SPF 35 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-2656
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	10 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)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARETH-25 (UNII: 8FA93U5T67)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
SORBIC ACID (UNII: X045WJ989B)
LAURETH-3 (UNII: F32E4CB0UJ)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)
AMMONIA (UNII: 5138Q19F1X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-2656-1	1 in 1 CARTON	05/16/2014
1		29 mL in 1 BOTTLE, PUMP; 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	05/16/2014

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-2656)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-2656)