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

Mary Kay Suncare SPF 50 Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

HOMOSALATE (10% W/W)

OCTOCRYLENE (5.50% W/W)

OXYBENZONE (5% W/W)

OCTISALATE (4.50% W/W)

AVOBENZONE (3% W/W)

Indications:

Protects from certain harmful UVA and UVB rays of the sun to help prevent sunburn.

Provides high sunburn protection but not 100% protection.

Retains its sun protection for 80 minutes in water.

Warnings:

For external use only.

Stop use and ask a doctor if rash occurs.

Do not use on damaged or broken skin.

If swallowed, get medical help or contact a poison control center immediately.

For use on children under 6 months of age, consult your doctor.

Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Keep out of reach of children.

Sun Alert: The sun may cause sunburn, premature aging of the skin and skin cancer.

Avoiding the sun, wearing protective clothing, sunglasses, and regular use of sunscreens over the years may reduce the chance of these harmful effects.

Keep babies and children out of direct sunlight.

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

Limit time in the sun, especially from 10 a.m. - 4 p.m.).

Wear long-sleeved shirts, pants, hats and sunglasses.

This product contains Oxybenzone.

Directions:

Adults and children older than 6 months of age: Apply a generous amount sufficiently at least 15 minutes before sun exposure.

Reapply at least every 2 hours.

Reapply after 80 minutes of swimming or sweating, and reapply immediately after towel drying.

Ingredients:

WATER/EAU, STYRENE/ACRYLATES COPOLYMER, BUTYLOCTYL SALICYLATE, 

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

spf 50 sunscreen

écran solaire fps 50

protector solar fps 50

lotion/loción

DIN 02410915

4 FL. OZ. / 118 mL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-3274
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: 51531-3274-4	1 in 1 CARTON	12/16/2013
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		12/16/2013

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-3274)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-3274)