MARY KAY TIMEWISE DAYTIME DEFENDER SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone/octisalate/octocrylene lotion

Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Mary Kay TimeWise Daytime Defender Sunscreen 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 3% (w/w)

Octisalate 4.5% (w/w)

Octocrylene 9% (w/w)

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Do not use

on broken skin.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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

Adults and children over 6 months of age: ■ apply liberally15 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 from10 a.m.–2 p.m. wear long-sleeve shirts, pants, hatsand sunglasses ■ children under 6 months: Ask a doctor

Other information

■ protect the product in this container from excessive heat and direct sun.

Inactive ingredients

water/eau/aqua, propanediol, glycerin, silica, caprylyl methicone, ceteareth-25, aluminum starch octenylsuccinate, ammonium acryloyldimethyltaurate/VP copolymer, beeswax/ cire d'abeille/cera alba, glyceryl stearate, niacinamide, dimethicone, phenoxyethanol, disodium ethylene dicocamide PEG-15 disulfate, VP/eicosene copolymer, hydroxyacetophenone, opuntia ficus-indica fruit extract, xanthan gum, disodium EDTA, ethylhexylglycerin, saccharomyces cerevisiae extract, sucrose stearate, alcohol, dipropylene glycol, ethyl macadamiate, resveratrol, sodium benzoate, tocopheryl acetate, oligopeptide-1.

Questions?

1-800-627-9529

Principal Display Panel - 29 ml carton

Mary Kay

TimeWise

DAYTIME DEFENDER
SUNSCREEN
BROAD SPECTRUM SPF 30

1 FL. OZ. / 29 mL

INGREDIENTS AND APPEARANCE

MARY KAY TIMEWISE DAYTIME DEFENDER SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone/octisalate/octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-7385
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
RESVERATROL (UNII: Q369O8926L)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
NIACINAMIDE (UNII: 25X51I8RD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETEARETH-25 (UNII: 8FA93U5T67)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SUCROSE STEARATE (UNII: 274KW0O50M)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
YELLOW WAX (UNII: 2ZA36H0S2V)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-7385-1	1 in 1 CARTON	07/20/2023
1		29.783 g 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	M020	07/20/2023

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-7385)