SPL v1
SPL
SPL Set ID 1cc19337-cf54-af5d-e063-6394a90a1ceb
Route
TOPICAL
Published
Effective Date 2024-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (30 mg) Titanium Dioxide (100 mg)
Inactive Ingredients
Ferric Oxide Yellow Bismuth Oxychloride Caprylhydroxamic Acid Caprylyl Glycol Ethylhexyl Hydroxystearate Benzoate Cyclomethicone 6 Cyclomethicone 5 Melissa Officinalis Whole Water Polyoxyl 20 Cetostearyl Ether Glycerin Isohexadecane Microcrystalline Wax Sodium Chloride Tetrahexyldecyl Ascorbate Ferric Oxide Red Octyldodecyl Neopentanoate .alpha.-tocopherol Acetate Edetate Disodium Anhydrous Medium-chain Triglycerides Dimethicone Ferrosoferric Oxide Peg-30 Dipolyhydroxystearate (4000 Mw) Triethoxycaprylylsilane Isododecane Mica Tocopherol Trolamine

Identifiers & Packaging

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

ACTIVE INGREDIENTS: Titanium Dioxide 10% Zinc Oxide 3%

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 caused by the sun.

Apply liberally 15 minutes before sun exposure.

Description

ACTIVE INGREDIENTS: Titanium Dioxide 10% Zinc Oxide 3%

Section 50565-1

Keep out of the reach of

children.

Section 51727-6

INACTIVE INGREDIENTS:

Bismuth Oxychloride, Capric/Caprylic Triglyceride,

Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20,

Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium

EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides,

Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint)

Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,

PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl

Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine,

Triethoxycaprylylsilane, Water

Section 51945-4

Principal Display Panel – 53 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

daily defense tinted

mineral sunscreen

broad spectrum spf 50

water resistant (40 minutes)

net wt. 1.8 oz / 53 g

Graphic-Untitled

Section 55105-1

PURPOSE:Sunscreen

Section 55106-9

ACTIVE INGREDIENTS:

Titanium Dioxide 10%

Zinc Oxide 3%

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 caused by the sun.

Apply liberally 15 minutes before 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:

Bismuth Oxychloride, Capric/Caprylic Triglyceride,

Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20,

Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium

EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides,

Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint)

Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,

PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl

Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine,

Triethoxycaprylylsilane, Water

Section 51945-4 (51945-4)

Principal Display Panel – 53 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

daily defense tinted

mineral sunscreen

broad spectrum spf 50

water resistant (40 minutes)

net wt. 1.8 oz / 53 g

Graphic-Untitled

Section 55105-1 (55105-1)

PURPOSE:Sunscreen

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Titanium Dioxide 10%

Zinc Oxide 3%

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:15.263569 · Updated: 2026-03-14T23:03:14.317302