84148-014

84148-014
SPL v1
SPL
SPL Set ID 42bc865f-29bd-da90-e063-6294a90aa16d
Route
CUTANEOUS
Published
Effective Date 2025-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (3 g) Titanium Dioxide (2 g)
Inactive Ingredients
Cyclopentasiloxane Dimethicone Dimethicone Crosspolymer Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Hydrogenated Coconut Oil Hydrolyzed Jojoba Esters Caprylyl Methicone Aluminum Hydroxide Triethoxycaprylylsilane Tetrahexyldecyl Ascorbate Stearic Acid Silica .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-04

Description

Zinc Oxide 3% Titanium Dioxide 2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 3% Titanium Dioxide 2%

Use

Helps prevent sunburn.Decreases the signs of early

skin aging and risk of skin disease caused by the

sun.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Discontinue use if redness or irritation occurs.

Section 50567-7

When using this product, avoid contact with eyes. If

contact occurs, rinse thoroughly with water.

Warnings

For external use only.

Store at room temperature.

Discontinue use if redness or irritation occurs.

Keep out of reach of children.

Rinse with water to remove.

If swallowed get medical help and contact a poison

control center right away.

Do not use on damaged or broken skin.

When using this product, avoid contact with eyes. If

contact occurs, rinse thoroughly with water.

Directions

1.Apply generous amount to skin 15 minutes before sun exposure.

2. Wait 10-15 minutes for sunscreen to be fully absorbed.

3. Reapply after 80 minutes of swimming or sweating.

4. Apply after immediately towel drying.

Do Not Use

Do not use on damaged or broken skin.

Other Information

Sunscreen may stain some fabrics.Protect this

product from direct exposure to sunlight or

excessive heat.

Active Ingredient(s)

Zinc Oxide 3%

Titanium Dioxide 2%

Inactive Ingredients

Alumine, Capny Mticone, Ccoentaloxane,

Dimethicone, Dimthicone Crosolymer,"

Diethicneneinyl Dmethicone Cosolmer

Hyrogenated Coconut oi, Jjioba Esters, Sliea

Stearc Acid, Ttateyded Acoraeraa Tcohev

Acetate, Trthoxyapryilane.

Package Label Principal Display Panel


Structured Label Content

Use

Helps prevent sunburn.Decreases the signs of early

skin aging and risk of skin disease caused by the

sun.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Discontinue use if redness or irritation occurs.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes. If

contact occurs, rinse thoroughly with water.

Purpose

Sunscreen

Warnings

For external use only.

Store at room temperature.

Discontinue use if redness or irritation occurs.

Keep out of reach of children.

Rinse with water to remove.

If swallowed get medical help and contact a poison

control center right away.

Do not use on damaged or broken skin.

When using this product, avoid contact with eyes. If

contact occurs, rinse thoroughly with water.

Directions

1.Apply generous amount to skin 15 minutes before sun exposure.

2. Wait 10-15 minutes for sunscreen to be fully absorbed.

3. Reapply after 80 minutes of swimming or sweating.

4. Apply after immediately towel drying.

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Other Information (Other information)

Sunscreen may stain some fabrics.Protect this

product from direct exposure to sunlight or

excessive heat.

Active Ingredient(s)

Zinc Oxide 3%

Titanium Dioxide 2%

Inactive Ingredients (Inactive ingredients)

Alumine, Capny Mticone, Ccoentaloxane,

Dimethicone, Dimthicone Crosolymer,"

Diethicneneinyl Dmethicone Cosolmer

Hyrogenated Coconut oi, Jjioba Esters, Sliea

Stearc Acid, Ttateyded Acoraeraa Tcohev

Acetate, Trthoxyapryilane.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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