Mary Kay Suncare Sunscreen SPF 30Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

MARY KAY SUNCARE SUNSCREEN SPF 30- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion 
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 Suncare Sunscreen SPF 30
Drug Facts

Active Ingredients

Avobenzone 2%

Homosalate 10%

Octinoxate 7.5%

Octisalate 5%

Oxybenzone 4%

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
• reapply:
•      after 80 munutes of swimming or sweating
•      immediately after towel drying
•      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

Inactive ingredients

ascorbyl palmitate, benzyl alcohol, bisabolol, butylene glycol, camellia sinensis leaf extract, cetyl dimethicone, chlorphenesin, dimethicone, disodium EDTA, ethylparaben, fragrance, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylparaben, PEG-100 stearate, phenoxyethanol, polysorbate 60, propylparaben, silica, sorbitan isostearate, squalane, steareth-2, tocopheryl acetate, trimethylpentanediol/adipic acid/glycerin crosspolymer, trimethylsiloxysilicate, vp/eicosene copolymer, water, xanthan gum

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-627-9529

Principal Display Panel - 118 mL carton

Mary Kay

suncare

sunscreen

broad spectrum spf 30

protector solar

con amplia proteccion solar fps 30

water resistant

(80 minutes)

a prueba de agua

(80 minutos)

4 FL. OZ. / 118 mL

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-0349
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-0349-4	1 in 1 CARTON	03/16/2007	04/05/2013
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
OTC monograph final	part352	03/16/2007	04/05/2013

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-0349)

Revised: 7/2019

Document Id: 6a859306-f091-4df1-bf63-39962b19fe43

34390-5

Set id: b1a48118-6ee8-45ef-a17e-d25e4d7332df

Version: 2

Effective Time: 20190731