MARY KAY SUNCARE SPF 30 SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Mary Kay SunCare SPF 30 Sunscreen by

Drug Labeling and Warnings

Mary Kay SunCare SPF 30 Sunscreen 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

Warnings:

For external use only, not to be swallowed.

If rash or irritation develops, discontinue use.

Avoid use in 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, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, BENZOPHENONE-3, TRIMETHYLPENTANEDIOL/
ADIPIC ACID/GLYCERIN CROSSPOLYMER, VP/EICOSENE COPOLYMER, BUTYL METHOXYDIBENZOYLMETHANE, SILICA, GLYCERIN,
BUTYLENE GLYCOL, ASCORBYL PALMITATE, TOCOPHERYL ACETATE, BISABOLOL, CAMELLIA SINENSIS LEAF EXTRACT, HYDROXYETHYL
ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, GLYCERYL STEARATE, DIMETHICONE, SQUALANE, PEG-100 STEARATE,
PHENOXYETHANOL, PARFUM, BENZYL ALCOHOL, XANTHAN GUM, METHYLPARABEN, CETYL DIMETHICONE, STEARETH-2, CHLORPHENESIN,
POLYSORBATE 60, DISODIUM EDTA, PROPYLPARABEN, TRIMETHYLSILOXYSILICATE, ETHYLPARABEN, SORBITAN ISOSTEARATE, GERANIOL.

Principal Display Panel - 118 ml carton

Mary Kay

suncare

spf 30 sunscreen UVA

high protection

118 mL

INGREDIENTS AND APPEARANCE

MARY KAY SUNCARE SPF 30 SUNSCREEN 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-9419
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 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)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
LEVOMENOL (UNII: 24WE03BX2T)
STEARETH-2 (UNII: V56DFE46J5)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ETHYLPARABEN (UNII: 14255EXE39)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-9419-4	1 in 1 CARTON	05/07/2013
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		05/07/2013

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-9419)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-9419)