Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1f41955b-a363-495c-91ef-2206efad07fe
Route
TOPICAL
Published
Effective Date 2014-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 g) Titanium Dioxide (50 g) Oxybenzone (45 g) Avobenzone (25 g)
Inactive Ingredients
Water Stearic Acid Avocado Oil Jojoba Oil Butyloctyl Salicylate Acetylated Lanolin Alcohols Honey Kiwi Fruit Hydrolysed Marine Collagen (enzymatic; 2000 Mw) .alpha.-tocopherol Acetate Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Trolamine Caprylhydroxamic Acid Phenoxyethanol Methylpropanediol Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-01

Description

Octinoxate 7,50% Titanium dioxide 5,00% Oxybenzone 4,50% Avobenzone 2,5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7,50% Titanium dioxide 5,00% Oxybenzone 4,50% Avobenzone 2,5%

Uses

Helps prevent sunburn

Section 50565-1

Keep out of reach of children.

If product is swalowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if any rush occurs.

Section 50567-7

When using this product, keep out of eyes.

Rinse with water to remove.

Section 51945-4






Warnings

For external use only.

Do not use on broken or damaged skin.

Directions

Apply liberally and evenly 15 minutes before sun exposure

Children under 6 months of age: Ask a doctor

Apply to all skin exposed to the sun

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10am-2pm.

 - wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun

Active Ingredients

Octinoxate 7,50%

Titanium dioxide 5,00%

Oxybenzone 4,50%

Avobenzone 2,5%

Inactive Ingredients

Aqua (water)

Stearic Acid

Persea Gratissima (Avocado) Oil

Simmondsia Chinensis (Jojoba) Oil

Butyloctyl salicylate

Acetylated Lanolin Alcohol

Leptospermum Scoparium Mel

Actinidia Chinensis (Kiwi) Fruit Extract

Hydrolyzed (Marine) Collagen

Tocopheryl Acetate (Vitamin E)

Carbomer

Cetyl Alcohol

Triethanolamine

Caprylhydroxamic Acid

Phenoxiethanol

Methylpropanediol

Tetrasodium EDTA


Structured Label Content

Uses (USES)

Helps prevent sunburn

Section 50565-1 (50565-1)

Keep out of reach of children.

If product is swalowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if any rush occurs.

Section 50567-7 (50567-7)

When using this product, keep out of eyes.

Rinse with water to remove.

Section 51945-4 (51945-4)






Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only.

Do not use on broken or damaged skin.

Directions (DIRECTIONS)

Apply liberally and evenly 15 minutes before sun exposure

Children under 6 months of age: Ask a doctor

Apply to all skin exposed to the sun

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10am-2pm.

 - wear long-sleeved shirts, pants, hats and sunglasses.

Other Information (OTHER INFORMATION)

Protect the product in this container from excessive heat and direct sun

Active Ingredients (ACTIVE INGREDIENTS)

Octinoxate 7,50%

Titanium dioxide 5,00%

Oxybenzone 4,50%

Avobenzone 2,5%

Inactive Ingredients (INACTIVE INGREDIENTS)

Aqua (water)

Stearic Acid

Persea Gratissima (Avocado) Oil

Simmondsia Chinensis (Jojoba) Oil

Butyloctyl salicylate

Acetylated Lanolin Alcohol

Leptospermum Scoparium Mel

Actinidia Chinensis (Kiwi) Fruit Extract

Hydrolyzed (Marine) Collagen

Tocopheryl Acetate (Vitamin E)

Carbomer

Cetyl Alcohol

Triethanolamine

Caprylhydroxamic Acid

Phenoxiethanol

Methylpropanediol

Tetrasodium EDTA


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)