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

Mary Kay Suncare Sunscreen SPF 50 by

Drug Labeling and Warnings

Mary Kay Suncare Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

UVA/UVB protection

Indications:

Helps to protect your skin from the damaging effects of the sun.

Protects from certain harmful UV rays of the sun to help prevent sunburn.

Warnings:

For external use only, not to be swallowed.

If rash or irritation develops, discontinue use.

Avoid use in the eye area.

Keep out of reach of children.

Do not stay too long in the sun, even while using a sunscreen product.

Overexposure to the sun is dangerous.

Avoid excessive sun exposure at peak hours (between 11 a.m. and 3 p.m.).

Keep yourself well covered (hat, clothing, sunglasses).

Contains Benzophenone-3.

Directions:

Apply liberally (about 6 teaspoons or 36 grams of sunscreen for the average adult body) at least 15 minutes before sun exposure.
Warning: Reducing this quantity will lower the level of protection significantly.
Re-apply every one to three hours to maintain protection, especially after swimming, toweling, vigorous activities or excessive sweating.

Ingredients:

AQUA, HOMOSALATE, OCTOCRYLENE, BENZOPHENONE-3, ETHYLHEXYL SALICYLATE,

STYRENE/ACRYLATES COPOLYMER, BUTYLOCTYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE,

BUTYLENE GLYCOL, CETEARYL ALCOHOL, CETETH-20 PHOSPHATE, METHYL TRIMETHICONE,

SILICA, ACRYLATES/DIMETHICONE COPOLYMER, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER,

ETHYLHEXYL METHOXYCRYLENE, VP/EICOSENE COPOLYMER, BEHENYL ALCOHOL, GLYCERIN,

DICETYL PHOSPHATE, PENTYLENE GLYCOL, DIMETHICONE, TRIMETHYLSILOXYSILICATE,

AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, PHENOXYETHANOL, CAPRYLYL GLYCOL,

TRIETHANOLAMINE, ETHYLENE BRASSYLATE, XANTHAN GUM, PROPYLENE GLYCOL, DISODIUM EDTA,

TOCOPHERYL ACETATE, SORBIC ACID, ISOBUTYL METHYL TETRAHYDROPYRANOL,

EUTERPE OLERACEA FRUIT EXTRACT, ETHYL LINALOOL, METHYLENEDIOXYPHENYL METHYLPROPANAL,

AMMONIUM HYDROXIDE, PHENYLISOHEXANOL, CYCLAMEN ALDEHYDE.

Principal Display Panel - 118 ml carton

Mary Kay

suncare

sunscreen

spf 50 sunscreen UVA

high protection

sonnenpflege lsf 50

hoher schutz

118 mL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-3275
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: 51531-3275-4	1 in 1 CARTON	03/16/2013
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
export only		03/16/2013

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-3275)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-3275)