e0ad02c3-f5ed-4b72-ba96-07d9c489a4ea

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

Purpose

Sunscreen

Description

Titanium Dioxide 3.3% Zinc Oxide 13.8%


Medication Information

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.

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

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.

Other Information

• protect this product from excessive heat and direct sun

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.

Description

Titanium Dioxide 3.3% Zinc Oxide 13.8%

Drug Facts

Product Label

Active Ingredients

Titanium Dioxide 3.3%

Zinc Oxide 13.8%

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

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.

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

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.

Other Information (Other information)

• protect this product from excessive heat and direct sun

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.

Drug Facts

Product Label (Product label)

Active Ingredients (Active ingredients)

Titanium Dioxide 3.3%

Zinc Oxide 13.8%

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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