SPL v2
SPL
SPL Set ID 1dda8259-4121-3c76-e063-6394a90af189
Route
TOPICAL
Published
Effective Date 2024-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Mica Bismuth Oxychloride Ferric Oxide Yellow Caprylyl Glycol Polysorbate 20 Alkyl (c12-15) Benzoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Edetate Disodium Dimethiconol (2000 Cst) Microcrystalline Wax Polyglyceryl-4 Isostearate Polyhydroxystearic Acid (2300 Mw) .alpha.-tocopherol Acetate Water Dimethicone 100 Peg-30 Dipolyhydroxystearate (4000 Mw) Hydrogen Dimethicone (20 Cst) Cyclomethicone 5 Stearyl Dimethicone (400 Mpa.s At 50c) Sodium Chloride Triethoxycaprylylsilane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Caprylhydroxamic Acid Cyclomethicone 6 Glycerin Peg-10 Dimethicone (600 Cst) Tetrahexyldecyl Ascorbate Trolamine Ferrosoferric Oxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-22

Description

ACTIVE INGREDIENTS:Zinc Oxide 20%


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 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 INGREDIENTS:Zinc Oxide 20%

Section 50565-1

Keep out of the reach of children.

Section 51727-6

INACTIVE INGREDIENTS:

Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl

Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane,

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium

EDTA, Glycerin, Iron Oxides, Hydrogren Dimethicone, Mica, Microcrystalline

Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4

Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride,

Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate,

Triethanolamine, Triethoxycaprylylsilane, Water

Section 51945-4

Principal Display Panel – 113 g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

non-tinted

mineral sunscreen

20% zinc oxide

broad spectrum spf 40

water resistant (40 minutes)

net wt. 4 oz/ 113 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 aging

caused by the sun.

Section 55106-9

ACTIVE INGREDIENTS:Zinc Oxide 20%

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 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:

Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl

Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane,

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium

EDTA, Glycerin, Iron Oxides, Hydrogren Dimethicone, Mica, Microcrystalline

Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4

Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride,

Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate,

Triethanolamine, Triethoxycaprylylsilane, Water

Section 51945-4 (51945-4)

Principal Display Panel – 113 g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

non-tinted

mineral sunscreen

20% zinc oxide

broad spectrum spf 40

water resistant (40 minutes)

net wt. 4 oz/ 113 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 aging

caused by the sun.

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:Zinc Oxide 20%

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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