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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Available from:
Mary Kay Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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
Authorization status:
OTC monograph final
Authorization number:
51531-2825-1

MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 DEEP- homosalate,

octinoxate, oxybenzone cream

Mary Kay Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mary Kay CC Cream Sunscreen SPF 15 Deep

Drug Facts

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

MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 DEEP

homosalate, octinoxate, oxybenzone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51531-28 25

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

5 g in 10 0 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

6 .5 g in 10 0 mL

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

1.2 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

GLYCERIN (UNII: PDC6 A3C0 OX)

PEG-9 PO LYDIMETHYLSILO XYETHYL DIMETHICO NE (UNII: TYP8 1E471F)

NIACINAMIDE (UNII: 25X51I8 RD4)

MICA (UNII: V8 A1AW0 8 8 0 )

PEG-9 DIMETHICO NE ( 4 0 0 CST) (UNII: 9 OZ27X0 6 5D)

MAGNESIUM SULFATE, UNSPECIFIED FO RM (UNII: DE0 8 0 37SAB)

ASCO RBYL GLUCO SIDE (UNII: 2V52R0 NHXW)

MILK THISTLE (UNII: U9 46 SH9 5EE)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

SALIX NIGRA BARK (UNII: QU52J3A5B3)

SALICYLIC ACID (UNII: O414PZ4LPZ)

ADENO SINE (UNII: K72T3FS56 7)

DISO DIUM STEARO YL GLUTAMATE (UNII: 45ASM2L11M)

XANTHAN GUM (UNII: TTV12P4NEE)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

CYCLO METHICO NE 6 (UNII: XHK3U310 BA)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Mary Kay Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51531-28 25-1

1 in 1 CARTON

0 2/16 /20 14

1

29 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 2/16 /20 14

Labeler -

Mary Kay Inc. (049994452)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Englewo o d Lab Inc.

0 8 0 36 6 9 0 3

ma nufa c ture (51531-28 25)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Mary Kay Inc.

10 39 78 8 39

ma nufa c ture (51531-28 25)

Revised: 8/2020

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