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]

ACTIVE INGREDIENTS:

AVOBENZONE (2% W/W)

HOMOSALATE (10% W/W)

OCTISALATE (5% W/W)

OCTINOXATE (7.5% W/W)

OXYBENZONE (4% 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, not to be swallowed.

Discontinue use if skin irritation develops or increases.

If irritation persists, consult a doctor.

For use on children less than six months of age, consult your doctor.

Avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Keep out of the reach of children.

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

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

Contains Oxybenzone.

Directions:

Apply a generous and sufficient amount at least 15 minutes before sun exposure.

Re-apply after 80 minutes of swimming, sweating, immediately after towel drying or other vigorous activities, and at least every 2 hours.

OTHER INGEDIENTS:

WATER/EAU, TRIMETHYLPENTANEDIOL/
ADIPIC ACID/GLYCERIN CROSSPOLYMER, VP/EICOSENE COPOLYMER, SILICA, GLYCERIN,
BUTYLENE GLYCOL, ASCORBYL PALMITATE, TOCOPHERYL ACETATE, BISABOLOL, CAMELLIA SINENSIS LEAF EXTRACT, HYDROXYETHYL
ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, GLYCERYL STEARATE, PHENOXYETHANOL, DIMETHICONE, SQUALANE, PEG-100 STEARATE, FRAGRANCE/PARFUM, BENZYL ALCOHOL, XANTHAN GUM, METHYLPARABEN, CETYL DIMETHICONE, STEARETH-2, CHLORPHENESIN,
POLYSORBATE 60, DISODIUM EDTA, PROPYLPARABEN, TRIMETHYLSILOXYSILICATE, SORBITAN ISOSTEARATE, ETHYLPARABEN.

Principal Display Panel - 118 ml carton

Mary Kay

suncare

spf 30 sunscreen

écran solaire fps 30

protector solar fps 30

DIN 02291460

4 FL. OZ. / 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: 51531-9775
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: 51531-9775-4	1 in 1 CARTON	07/05/2013
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		07/05/2013

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-9775)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-9775)