2c4eaf2e-b034-8185-e063-6394a90a8275

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

Purpose

Sunscreen

Description

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


Medication Information

Uses

Helps prevent sunburn.

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.

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.

Description

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

Questions?

1-800-627-9529

Section 51945-4

MARY KAY

50

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

4 FL. OZ. / 118 mL

Do Not Use

on broken skin.

Active Ingredients

Avobenzone 3% (w/w)

Octisalate 4.5% (w/w)

Octocrylene 9% (w/w)

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.

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.

Other Information (Other information)

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

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.

Questions?

1-800-627-9529

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

Do Not Use (Do not use)

on broken skin.

Active Ingredients

Avobenzone 3% (w/w)

Octisalate 4.5% (w/w)

Octocrylene 9% (w/w)

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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