SPL v4
SPL
SPL Set ID 47dd9d8a-0df3-6596-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2013-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (4.5 g) Octisalate (3.2 g) Octocrylene (2.4 g) Avobenzone (3 g)
Inactive Ingredients
Mineral Oil Caprylyl Glycol Diethylhexyl 2,6-naphthalate Isopropyl Myristate Coconut Oil Grape Seed Oil Theobroma Cacao Whole .alpha.-tocopherol Acetate Aloe Vera Leaf Sunflower Oil Corn Oil Carrot Banana Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-01-01

Description

Avobenzone 3.0%, Homosalate 4.5%, Octisalate 3.2%, Octocrylene 2.4%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 4.5%, Octisalate 3.2%, Octocrylene 2.4%

Uses

Helps prevent sunburn

Section 51945-4

BANANA

BOAT®

TANNING

SPRAY OIL

SUNSCREEN SPRAY SPF 8

8

WITH COCONUT OIL

Skin Nourishing Formula

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

BANANA

BOAT

Spray Oil

UVA/UVB PROTECTION SUNSCREEN

8

BROAD SPECTRUM SPF 8

CARROT & BANANA EXTRACTS

WATER RESISTANT (80 MINUTES)

SWIM SPLASH SPORT

Warnings

For external use only

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 help prevent sunburn, not skin cancer or early skin aging.

Directions

Apply liberally 15 minutes before sun exposure; • Do not spray directly into face. Spray on hands and 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 3.0%, Homosalate 4.5%, Octisalate 3.2%, Octocrylene 2.4%

Inactive Ingredients

Mineral Oil, C12-15 Alkyl Benzoate, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Isopropyl Myristate, Coconut Oil, Grape Seed Oil, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter),Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract,Phenoxyethanol, Fragrance.

Questions & 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. May stain some fabrics


Structured Label Content

Uses

Helps prevent sunburn

Section 51945-4 (51945-4)

BANANA

BOAT®

TANNING

SPRAY OIL

SUNSCREEN SPRAY SPF 8

8

WITH COCONUT OIL

Skin Nourishing Formula

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

BANANA

BOAT

Spray Oil

UVA/UVB PROTECTION SUNSCREEN

8

BROAD SPECTRUM SPF 8

CARROT & BANANA EXTRACTS

WATER RESISTANT (80 MINUTES)

SWIM SPLASH SPORT

Purpose

Sunscreen

Warnings

For external use only

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 help prevent sunburn, not skin cancer or early skin aging.

Directions

Apply liberally 15 minutes before sun exposure; • Do not spray directly into face. Spray on hands and 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

protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 4.5%, Octisalate 3.2%, Octocrylene 2.4%

Inactive Ingredients (Inactive ingredients)

Mineral Oil, C12-15 Alkyl Benzoate, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Isopropyl Myristate, Coconut Oil, Grape Seed Oil, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter),Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract,Phenoxyethanol, Fragrance.

Questions & Comments? (Questions & 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. May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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