MARY KAY SUN PROTECTOR SPF 35- avobenzone, homosalate, octisalate, oxybenzone cream

Mary Kay Sun Protector SPF 35 by

Drug Labeling and Warnings

Mary Kay Sun Protector SPF 35 by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc., Le Papillon, Ltd., Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Broad-spectrum UVA/UVB protection.

INDICATIONS & USAGE

• Suitable for sensitive skin.
• Dermatologist-tested.
• Tested for Asian skin.

Warnings

Contains Oxybenzone. For external use only. Not to be swallowed. Avoid contact with the eyes. Discontinue use if signs of irritation or rash appear. Do not use on children under 3 years of age. Keep out of the reach of children. Do not stay too long in the sun, even when using a sunscreen product.

Directions

Smooth on liberally after moisturizer. Apply prior to sun exposure and as often as necessary.

INGREDIENTS

WATER, HOMOSALATE, DIMETHICONE, OCTISALATE, OXYBENZONE, STYRENE/ACRYLATES
COPOLYMER, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, DICAPRYLYL
CARBONATE, OCTOCRYLENE, AVOBENZONE, GLYCERIN, CETEARETH-25, DIMETHICONE CROSSPOLYMER,
MAGNESIUM ALUMINUM SILICATE, DIPROPYLENE GLYCOL DIBENZOATE,
ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, PHENOXYETHANOL, DISODIUM ETHYLENE
DICOCAMIDE PEG-15 DISULFATE, PENTYLENE GLYCOL, TOCOPHERYL
ACETATE, CAPRYLYL GLYCOL, HYDROGENATED LECITHIN, XANTHAN GUM, PPG-15 STEARYL ETHER
BENZOATE, DISODIUM EDTA, ETHYLENE BRASSYLATE, PROPYLENE GLYCOL, PEG-4 LAURATE, SORBIC
ACID, ISOBUTYL METHYL TETRAHYDROPYRANOL, IODOPROPYNYL BUTYLCARBAMATE, ETHYL LINALOOL, METHYLENEDIOXYPHENYL METHYLPROPANAL, AMMONIUM HYDROXIDE, PHENYLISOHEXANOL, CYCLAMEN ALDEHYDE.

Principal Display Panel - 59 mL carton

Mary Kay

sun protector SPF 35 / PA+++

2.0 FL. OZ. / 59 mL

INGREDIENTS AND APPEARANCE

MARY KAY SUN PROTECTOR SPF 35 
avobenzone, homosalate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-8450
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARETH-25 (UNII: 8FA93U5T67)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
XANTHAN GUM (UNII: TTV12P4NEE)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBIC ACID (UNII: X045WJ989B)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
PHENYLISOHEXANOL (UNII: M56178H183)
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-8450-2	1 in 1 CARTON	06/26/2013
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51531-8450-0	0.49 mL in 1 PACKET; Type 0: Not a Combination Product	06/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		06/26/2013

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-8450)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-8450)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080987545	pack(51531-8450)

Establishment
Name	Address	ID/FEI	Business Operations
Le Papillon, Ltd.		040070823	pack(51531-8450)