SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY- avobenzone/octisalate/octocrylene lotion

SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY by

Drug Labeling and Warnings

SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY 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 3% (w/w)

Octisalate 4.5% (w/w)

Octocrylene 9% (w/w)

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

Do not use

on broken skin.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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

Adults and children over 6 months of age: ■ apply liberally 15 minutes before sun exposure. ■ Reapply: after 80 minutes 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m.; and wear long-sleeved shirts, pants, hats, and sunglasses. ■ Children under 6 months: Ask a doctor.

Other information

■ protect the product in this container from excessive heat and direct sun.

Inactive ingredients

water/eau/aqua, propanediol, VP/eicosene copolymer, glycerin, caprylyl methicone, phenoxyethanol, acrylates/C10-30 alkyl acrylate crosspolymer, cetearyl alcohol, hydroxyacetophenone, disodium edta, xanthan gum, potassium hydroxide, ethylhexylglycerin.

Questions?

1-800-627-9529

PRINCIPAL DISPLAY PANEL

MARY KAY

50

SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY water-resistant (80 minutes)

4 FL. OZ. / 118 mL

INGREDIENTS AND APPEARANCE

SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY 
avobenzone/octisalate/octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-7287
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-7287-1	1 in 1 CARTON	03/01/2025
1		118 g 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 Drug	M020	03/01/2025

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-7287)