MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 MEDIUM TO DEEP- homosalate, octinoxate, oxybenzone cream

Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep by

Drug Labeling and Warnings

Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc., Englewood Lab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 5%

Octinoxate 6.5%

Oxybenzone 1.2 %

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
•      use a water resistant sunscreen if swimming or sweating
•      reapply at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
•      limit time in the sun, especially from 10 a.m. - 2 p.m.
•      wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor

Other information

• Store at 25°C (77°F). Do not freeze or refrigerate.

Inactive ingredients

water, cyclopentasiloxane, butylene glycol, glycerin, PEG-9 polydimethylsiloxyethyl dimethicone, niacinamide, mica, PEG-9 dimethicone, magnesium sulfate, ascorbyl glucoside, silybum marianum fruit extract, tocopheryl acetate, salix nigra (willow) bark extract, salicylic acid, adenosine, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, xanthan gum, dipropylene glycol, disodium EDTA, cyclohexasiloxane, sodium citrate, tocopherol, sorbic acid, sodium benzoate, benzyl alcohol, aluminum hydroxide, titanium dioxide, iron oxides

Questions or comments?

Call toll free 1-800-627-9529

Principal Display Panel - 29 ml carton

Mary Kay

cc cream

sunscreen broad

spectrum spf 15

cream

1 FL. OZ. / 29 mL

INGREDIENTS AND APPEARANCE

MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 MEDIUM TO DEEP 
homosalate, octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-2824
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
NIACINAMIDE (UNII: 25X51I8RD4)
MICA (UNII: V8A1AW0880)
PEG-9 DIMETHICONE (400 CST) (UNII: 9OZ27X065D)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
MILK THISTLE (UNII: U946SH95EE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
SALICYLIC ACID (UNII: O414PZ4LPZ)
ADENOSINE (UNII: K72T3FS567)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
XANTHAN GUM (UNII: TTV12P4NEE)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBIC ACID (UNII: X045WJ989B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-2824-1	1 in 1 CARTON	02/16/2014
1		29 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
OTC monograph final	part352	02/16/2014

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-2824)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-2824)