SPL v1
SPL
SPL Set ID 1cbcf8a6-0e83-f759-e063-6394a90ac14d
Route
TOPICAL
Published
Effective Date 2024-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg)
Inactive Ingredients
Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethicone 20 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Hydrogen Dimethicone (20 Cst) Brown Iron Oxide .alpha.-tocopherol Acetate Cyclomethicone 5 Cyclomethicone 6 Peg-10 Dimethicone (600 Cst) Tetrahexyldecyl Ascorbate Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Medium-chain Triglycerides Dimethiconol (2000 Cst) Ceramide 3 Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-08

Description

ACTIVE INGREDIENT:Zinc Oxide 16%


Medication Information

Warnings and Precautions

WARNINGS:For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

DIRECTIONS:

• Apply liberally 15 minutes before sun exposure.

• Reapply:

• After 40 minutes of swimming or sweating

• Immediately after towel drying

• At least every 2 hours

• 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 10 am-2 pm

• Wear long-sleeved shirts, pants, hats, and sunglasses

Dosage and Administration

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging cuased by the sun.

Apply liberally 15 minutes befor sun exposure.

Description

ACTIVE INGREDIENT:Zinc Oxide 16%

Section 50565-1

Keep out of the reach of children.

Section 51727-6

INACTIVE INGREDIENTS: Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane

Crosspolymer

Section 51945-4

Principal Display Panel – 50g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

tinted replenishing

daily protection

broad spectrum spf 40

with ceramides, zinc oxide

& antioxidants C & E

net wt. 1.75 oz / 50 g

Graphic-Untitled

Section 55105-1

PURPOSE:Sunscreen

USES: Helps prevent 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.

Section 55106-9

ACTIVE INGREDIENT:Zinc Oxide 16%

Section 60561-8

OTHER INFORMATION:

• Protect this product from excessive heat and direct sun

• May stain some fabrics.


Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS:

• Apply liberally 15 minutes before sun exposure.

• Reapply:

• After 40 minutes of swimming or sweating

• Immediately after towel drying

• At least every 2 hours

• 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 10 am-2 pm

• Wear long-sleeved shirts, pants, hats, and sunglasses

Dosage and Administration (34068-7)

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging cuased by the sun.

Apply liberally 15 minutes befor sun exposure.

Warnings and Precautions (34071-1)

WARNINGS:For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane

Crosspolymer

Section 51945-4 (51945-4)

Principal Display Panel – 50g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

tinted replenishing

daily protection

broad spectrum spf 40

with ceramides, zinc oxide

& antioxidants C & E

net wt. 1.75 oz / 50 g

Graphic-Untitled

Section 55105-1 (55105-1)

PURPOSE:Sunscreen

USES: Helps prevent 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.

Section 55106-9 (55106-9)

ACTIVE INGREDIENT:Zinc Oxide 16%

Section 60561-8 (60561-8)

OTHER INFORMATION:

• Protect this product from excessive heat and direct sun

• May stain some fabrics.


Advanced Ingredient Data


Raw Label Data

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