MARY KAY TIMEWISE DAY SOLUTION SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Mary Kay TimeWise Day Solution SPF 30 by

Drug Labeling and Warnings

Mary Kay TimeWise Day Solution SPF 30 by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc., Englewood Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

HOMOSALATE (10.0% W/W)

OCTYL SALICYLATE (5.0% W/W)

OXYBENZONE (4.0% W/W)

OCTOCRYLENE (2.0% W/W)

BUTYL METHOXYDIBENZOYLMETHANE (2.0% W/W)

Warnings:

Avoid contact with eyes. Should not be used on broken, damaged, or diseased skin. Store below 30° C.

Directions for use:

Apply generous amounts of sunscreen over all exposed areas 15 to 20 minutes
before sun exposure and again after swimming or towel drying. Avoid prolonged exposure to the sun, and wear
protective clothing, hat and eyewear.

Ingredients:

PURIFIED WATER, HOMOSALATE, DIMETHICONE-5, OCTYL SALICYLATE, OXYBENXONE, 1,3-BUTYLENE GLYCOL, STYRENE/ACRYLATES COPOLYMER, C12-15 ALKYL BENZOATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE, DICAPRYLYL CARBONATE, GLYCEROL, CETEARETH-25, DIMETHICONE CROSSPOLYMER, ALUMINIUM MAGNESIUM SILICATE, DIPROPYLENE GLYCOL DIBENZOATE, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, PHENOXYETHANOL, DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE, PENTYLENE GLYCOL, dl-ALPHA TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, HYDROGENATED LECITHIN, XANTHAN GUM, PROPYLENE GLYCOL, PPG-15 STEARYL ETHER BENZOATE, DISODIUM EDETATE, PEG-4 LAURATE, SORBIC ACID, LAURETH-3, HYDROXYETHYLCELLULOSE, IODOPROPYNYL BUTYLCARBAMATE, ACETYL DIPEPTIDE-1 CETYL ESTER, AMMONIUM HYDROXIDE, CYCLOMETHICONE, CRITHMUM MARITIMUM WHOLE PLANT EXTRACT 1:9 IN 50% PROPYLENE GLYCOL: W ICID 2004, ASCORBIC ACID, HYDROLYSED ALGIN, POTASSIUM SORBATE, PEG-75 (MACROGOL 3350), PEG-150 (MACROGOL 6000), PEG-8 CETYL DIMETHICONE, LECITHIN, ANACYSTIS NIDULANS FERMENT, BIOTIN.

Principal Display Panel - 29 ml carton

Mary Kay

timewise

day solution

sunscreen spf 30

broad spectrum

facial lotion

AUST L 211114

NET CONTENTS

1 FL. OZ. / 29 ml

INGREDIENTS AND APPEARANCE

MARY KAY TIMEWISE DAY SOLUTION SPF 30  BROAD SPECTRUM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-5231
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARETH-25 (UNII: 8FA93U5T67)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
SORBIC ACID (UNII: X045WJ989B)
LAURETH-3 (UNII: F32E4CB0UJ)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
N-ACETYL DIPEPTIDE-1 (UNII: HA41Z1UF8D)
AMMONIA (UNII: 5138Q19F1X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-5231-1	1 in 1 CARTON	10/08/2018
1		29 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		10/08/2018

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Labs Inc.		080987545	manufacture(51531-5231)