SPL v4
SPL
SPL Set ID e0ad02c3-f5ed-4b72-ba96-07d9c489a4ea
Route
TOPICAL
Published
Effective Date 2021-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.3 g) Zinc Oxide (13.8 g)
Inactive Ingredients
Cyclomethicone 5 Peg-10 Dimethicone (600 Cst) Hydrogenated Polydecene Type I Butylene Glycol Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Hydrogen Dimethicone (13 Cst) Acrylic Acid/ethylene Copolymer (600 Mpa.s) Silicon Dioxide Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Disteardimonium Hectorite Olea Europaea Leaf Phenoxyethanol Sodium Chloride Aluminum Hydroxide Allantoin Sodium Citrate Water Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-01

Description

Titanium Dioxide 3.3% Zinc Oxide 13.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.3% Zinc Oxide 13.8%

Uses

• helps prevent sunburn

• provides high protection against sunburn

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

Warnings

For External Use Only

Do not use ondamaged or broken skin.

When using this product

• Keep out of eyes.

• Rinse with water to remove.

Stop use and ask a doctorif rash or irritation develops and lasts.

Directions

• Apply liberally 15 minutes before sun exposure.

• Apply to all skin exposed to the sun.

• Reapply at least every 2 hours.

• Use a water resistant sunscreen if swimming or sweating.

• Children under 6 months: ask a doctor.

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 10a.m.-2p.m. 

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

Drug Facts

Product Label

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Titanium Dioxide 3.3%

Zinc Oxide 13.8%

Inactive Ingredients

Water, Cyclopentasiloxane, PEG-10 Dimethicone, Hydrogenated Polydecene, Butylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogen Dimethicone, Ethylene/Acrylic Acid Copolymer, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Olea Europaea Leaf Extract, Phenoxyethanol, Sodium Chloride, Aluminium Hydroxide, Allantoin, Sodium Citrate, Ethylhexylglycerin.

Questions Or Comments

(302) 291-7376

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

• provides high protection against sunburn

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

Purpose

Sunscreen

Warnings

For External Use Only

Do not use ondamaged or broken skin.

When using this product

• Keep out of eyes.

• Rinse with water to remove.

Stop use and ask a doctorif rash or irritation develops and lasts.

Directions

• Apply liberally 15 minutes before sun exposure.

• Apply to all skin exposed to the sun.

• Reapply at least every 2 hours.

• Use a water resistant sunscreen if swimming or sweating.

• Children under 6 months: ask a doctor.

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 10a.m.-2p.m. 

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

Drug Facts

Product Label (Product label)

Other Information (Other information)

• protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Titanium Dioxide 3.3%

Zinc Oxide 13.8%

Inactive Ingredients

Water, Cyclopentasiloxane, PEG-10 Dimethicone, Hydrogenated Polydecene, Butylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogen Dimethicone, Ethylene/Acrylic Acid Copolymer, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Olea Europaea Leaf Extract, Phenoxyethanol, Sodium Chloride, Aluminium Hydroxide, Allantoin, Sodium Citrate, Ethylhexylglycerin.

Questions Or Comments (Questions or comments)

(302) 291-7376

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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