SPL v3
SPL
SPL Set ID ab8623e2-0539-3f8f-e053-2a95a90a39d5
Route
TOPICAL
Published
Effective Date 2020-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.5 g) Octisalate (4 g)
Inactive Ingredients
Cocoa Butter Sunflower Oil Corn Oil Banana Mineral Oil Diisopropyl Adipate Carrot Coconut Oil .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-29

Description

Avobenzone 0.5%, Octisalate 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 0.5%, Octisalate 4.0%

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

May stain some fabrics.

Directions

• apply liberally 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 0.5%, Octisalate 4.0%

Inactive Ingredients

Mineral Oil, Diisopropyl Adipate, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Zea Mays (Corn) Oil, Musa Sapientum (Banana) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract

Primary Display Panel

BANANA

BOAT®

DEEP TANNING

SPRAY OIL

SUNSCREEN SPRAY SPF 4

4

WITH COCONUT OIL

FREE FROM

Oxybenzone

Octinoxate

Skin Nourishing Formula

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

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

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

May stain some fabrics.

Directions

• apply liberally 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 0.5%, Octisalate 4.0%

Inactive Ingredients (Inactive ingredients)

Mineral Oil, Diisopropyl Adipate, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Zea Mays (Corn) Oil, Musa Sapientum (Banana) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract

Primary Display Panel

BANANA

BOAT®

DEEP TANNING

SPRAY OIL

SUNSCREEN SPRAY SPF 4

4

WITH COCONUT OIL

FREE FROM

Oxybenzone

Octinoxate

Skin Nourishing Formula

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

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 (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

All Sections (JSON)