SPL v1
SPL
SPL Set ID 28f08236-1f01-d759-e063-6294a90adcfa
Route
TOPICAL
Published
Effective Date 2024-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5.2 g) Avobenzone (2.7 g) Octisalate (4.5 g)
Inactive Ingredients
Water .alpha.-tocopherol Acetate Glycerin Mangifera Indica (mango) Seed Butter Sodium Ascorbyl Phosphate Panthenol Phenoxyethanol Caprylyl Glycol Oryza Sativa (rice) Starch Xanthan Gum Carthamus Tinctorius (safflower) Seed Oil Carbomer Chlorphenesin Alkyl (c12-15) Benzoate Aloe Barbadensis Leaf Juice Edetate Disodium Alcohol Sodium Hydroxide Gluconolactone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

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 this product from excessive heatand direct sun

Active Ingredients

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

Inactive Ingredients

Water, Carthamus Tinctorius (Safflower) Seed Oil, C12-15 Alkyl Benzoate, Oryza Sativa (Rice) Starch, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol Denat., Phenoxyethanol, Caprylyl Glycol, Carbomer, Chlorphenesin, Sodium Hydroxide, Gluconolactone, Xanthan Gum, Disodium EDTA, Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate

Package Display Panel

NEW!

BANANA BOAT

baby

BROAD SPECTRUM SPF50 UVA/UVB

SUNSCREEN LOTION

50+

GENTLE ON SKIN

WON'T RUN INTO EYES

NO OXYBENZONE OR DYES

FRAGRANCE FREE

PEDIATRICIAN TESTED

WATER RESISTANT

(80 MINUTES)

6 FL.OZ. (177mL)

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

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 this product from excessive heatand direct sun

Active Ingredients

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

Inactive Ingredients

Water, Carthamus Tinctorius (Safflower) Seed Oil, C12-15 Alkyl Benzoate, Oryza Sativa (Rice) Starch, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol Denat., Phenoxyethanol, Caprylyl Glycol, Carbomer, Chlorphenesin, Sodium Hydroxide, Gluconolactone, Xanthan Gum, Disodium EDTA, Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate

Package Display Panel

NEW!

BANANA BOAT

baby

BROAD SPECTRUM SPF50 UVA/UVB

SUNSCREEN LOTION

50+

GENTLE ON SKIN

WON'T RUN INTO EYES

NO OXYBENZONE OR DYES

FRAGRANCE FREE

PEDIATRICIAN TESTED

WATER RESISTANT

(80 MINUTES)

6 FL.OZ. (177mL)

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (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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