MARY KAY SUNCARE SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Mary Kay Suncare Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Mary Kay Suncare Sunscreen Broad Spectrum SPF 50 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%

Homosalate 10%

Octisalate 4.5%

Octocrylene 5.5%

Oxybenzone 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
reapply:
   after 80 munutes of swimming or sweating
    immediately after towel drying
   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

acrylates/C12-22 alkyl methacrylate copolymer, acrylates/dimethicone copolymer,

ammonium acryloyldimethyltaurate/vp copolymer, ammonium hydroxide, behenyl alcohol,

butylene glycol, butyloctyl salicylate, caprylyl glycol,

cetearyl alcohol, ceteth-20 phosphate, cyclamen

aldehyde, dicetyl phosphate, dimethicone, disodium

EDTA, ethyl linalool, ethylene brassylate, ethylhexyl

methoxycrylene, euterpe oleracea

fruit extract, glycerin, isobutyl methyl

tetrahydropyranol, methyl trimethicone, methylenedioxyphenyl

methylpropanal, pentylene glycol, phenoxyethanol, phenylisohexanol,

propylene glycol, silica, sorbic acid,

styrene/acrylates copolymer, tocopheryl acetate,

triethanolamine, trimethylsiloxysilicate, vp/eicosene

copolymer, water, xanthan gum

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-627-9529

Principal Display Panel - 118 mL carton

Mary Kay

suncare

sunscreen

broad spectrum spf 50

protector solar

con amplia proteccion solar fps 50

water resistant

(80 minutes)

a prueba de agua

(80 minutos)

4 FL. OZ. / 118 mL

INGREDIENTS AND APPEARANCE

MARY KAY SUNCARE SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-3276
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DOCOSANOL (UNII: 9G1OE216XY)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GLYCERIN (UNII: PDC6A3C0OX)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TROLAMINE (UNII: 9O3K93S3TK)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBIC ACID (UNII: X045WJ989B)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
ACAI (UNII: 46AM2VJ0AW)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
AMMONIA (UNII: 5138Q19F1X)
PHENYLISOHEXANOL (UNII: M56178H183)
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-3276-4	1 in 1 CARTON	03/16/2014
1		118 mL 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	03/16/2014

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-3276)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-3276)