Mary Kay TimeWise Body Hand and Decolette Cream SPF 15Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

MARY KAY TIMEWISE BODY HAND AND DECOLETTE CREAM SPF 15- avobenzone, octisalate, octocrylene, oxybenzone cream 
Mary Kay Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mary Kay TimeWise Body Hand and Decolette Cream SPF 15
Drug Facts

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 2.2%

Oxybenzone 3%

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 warm 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, distearyldimonium chloride, butylene glycol, C12-15 alkyl

benzoate, cetyl alcohol, butyrospermum parkii (shea) butter, dimethicone,

steareth-21, niacinamide, dipropylene glycol dibenzoate, phenoxyethanol,

punica granatum sterols, tocopheryl acetate, silica, PPG-15 stearyl ether benzoate,

methylparaben, disodium EDTA, hydrogenated lecithin, ethylene brassylate, ethylparaben,

sodium chloride, propylparaben, triethanolamine, euterpe oleracea fruit extract,

isobutyl methyl tetrahydropyranol, ethyl linalool, methylenedioxyphenyl methylpropanal,

phenylisohexanol, cyclamen aldehyde, caprooyl tetrapeptide-3

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-627-9529

Principal Display Panel - 85 g carton

Mary Kay

timewise body

hand and decolette cream

sunscreen

broad spectrum spf 15

crema para manos y escote

con amplia proteccion

solar fps 15

3 OZ. NET WT./ 85 g

Principal Display Panel - 21 g carton

Mary Kay

timewise body

hand and decolette cream

sunscreen

broad spectrum spf 15

.75 OZ. NET WT./ 21 g

MARY KAY TIMEWISE BODY HAND AND DECOLETTE CREAM SPF 15 
avobenzone, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-4325
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-21 (UNII: 53J3F32P58)
NIACINAMIDE (UNII: 25X51I8RD4)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYLPARABEN (UNII: 14255EXE39)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
ACAI (UNII: 46AM2VJ0AW)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
PHENYLISOHEXANOL (UNII: M56178H183)
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)
CAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-4325-7	1 in 1 CARTON	03/15/2010	07/16/2014
1		21 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51531-4325-3	1 in 1 CARTON	03/15/2010	07/16/2014
2		85 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	03/15/2010	07/16/2014

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-4325)

Revised: 7/2019

Document Id: 187a240e-7159-4f0c-9391-7007037816a1

34390-5

Set id: 27d8e6ce-2450-410b-9d30-a320241e8ed3

Version: 2

Effective Time: 20190726