SPL v1
SPL
SPL Set ID 2c4eaf2e-b034-8185-e063-6394a90a8275
Route
TOPICAL
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9 g) Avobenzone (3 g) Octisalate (4.5 g)
Inactive Ingredients
Caprylyl Methicone Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Ethylhexylglycerin Glycerin Cetearyl Alcohol Potassium Hydroxide Vinylpyrrolidone/eicosene Copolymer Water Propanediol Edetate Disodium Xanthan Gum Phenoxyethanol Hydroxyacetophenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Avobenzone 3% (w/w) Octisalate 4.5% (w/w) Octocrylene 9% (w/w)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% (w/w) Octisalate 4.5% (w/w) Octocrylene 9% (w/w)

Uses

Helps prevent sunburn.

Section 51945-4

MARY KAY

50

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

4 FL. OZ. / 118 mL

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.

Do Not Use

on broken skin.

Questions?

1-800-627-9529

Other Information

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

Active Ingredients

Avobenzone 3% (w/w)

Octisalate 4.5% (w/w)

Octocrylene 9% (w/w)

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.

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.


Structured Label Content

Uses

Helps prevent sunburn.

Section 51945-4 (51945-4)

MARY KAY

50

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

4 FL. OZ. / 118 mL

Purpose

Sunscreen

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.

Do Not Use (Do not use)

on broken skin.

Questions?

1-800-627-9529

Other Information (Other information)

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

Active Ingredients

Avobenzone 3% (w/w)

Octisalate 4.5% (w/w)

Octocrylene 9% (w/w)

Inactive Ingredients (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.

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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