SPL v1
SPL
SPL Set ID 22e2b447-bd6b-5e8a-e063-6394a90a0de9
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9 g) Octisalate (4.5 g) Octocrylene (6.5 g) Avobenzone (2.7 g)
Inactive Ingredients
Dimethicone Chlorphenesin .alpha.-tocopherol Acetate Cetostearyl Alcohol Glyceryl Monostearate Aloe Vera Leaf Edetate Disodium Water Glycerin Peg-100 Stearate Silicon Dioxide Phenoxyethanol Xanthan Gum Caprylyl Glycol Sodium Polyacrylate (2500000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Uses

•helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.



May stain some fabrics.

Directions

• Shake well • 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. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Do Not Use

• on damaged or broken skin.

Other Information

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

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Inactive Ingredients:

Water, Glycerin, Silica, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Cetearyl Alcohol, Sodium Polyacrylate, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Xanthan Gum, Fragrance, Disodium EDTA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT

NEW &

IMPROVED

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 60+

60+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

8 FL.OZ. (236 mL)

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.


Structured Label Content

Uses

•helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only.



May stain some fabrics.

Directions

• Shake well • 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. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Do Not Use (Do not use)

• on damaged or broken skin.

Other Information

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

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Inactive Ingredients:

Water, Glycerin, Silica, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Cetearyl Alcohol, Sodium Polyacrylate, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Xanthan Gum, Fragrance, Disodium EDTA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT

NEW &

IMPROVED

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 60+

60+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

8 FL.OZ. (236 mL)

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

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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