SPL v2
SPL
SPL Set ID 231af290-99ee-e94d-e063-6394a90a0bef
Route
TOPICAL
Published
Effective Date 2024-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (90 mg)
Inactive Ingredients
Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Caprylhydroxamic Acid Corallina Officinalis Polysorbate 20 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Hydrogen Dimethicone (20 Cst) Cyclomethicone 6 Cyclomethicone 5 Peg-10 Dimethicone (600 Cst) Dimethiconol (2000 Cst) Lauryl Peg/ppg-18/18 Methicone Carbomer Homopolymer, Unspecified Type Caprylyl Glycol Silanetriol Glycerin Isohexadecane Undaria Pinnatifida Saccharomyces Cerevisiae Butylene Glycol Caffeine Isododecane Palmitoyl Tripeptide-1 Water Palmitoyl Tetrapeptide-7 Sambucus Nigra Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-27
Description

ACTIVE INGREDIENT: Zinc Oxide 9%

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

• Use a water resistant product if swimming or sweating.

• Reapply 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 INGREDIENT: Zinc Oxide 9%

Section 50565-1

Keep out of the reach of

children.

Section 51727-6

INACTIVE INGREDIENTS: Butylene Glycol, Caffeine,

Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina

Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane,

Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone

Crosspolymer, Dimethiconol, Glycerin, Hydrogen

Dimethicone, Isododecane, Isohexadecane, Lauryl

PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl

Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20,

Saccharomyces/Selenium Ferment, Sambucus Nigra Flower

Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate,

Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Section 51945-4

Principal Display Panel – 15 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

eye repair non-tinted

mineral sunscreen

broad spectrum spf 20 with

gentle zinc oxide, peptides

& botanical blend

net wt. 0.5 oz. / 15 g

Graphic-Untitled

Section 55105-1

PURPOSE:Sunscreen

Section 55106-9

ACTIVE INGREDIENT: Zinc Oxide 9%

Section 60561-8

OTHER INFORMATION: • Protect this product from excessive

heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS: • Apply liberally 15 minutes before sun exposure

• Use a water resistant product if swimming or sweating.

• Reapply 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 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: Butylene Glycol, Caffeine,

Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina

Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane,

Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone

Crosspolymer, Dimethiconol, Glycerin, Hydrogen

Dimethicone, Isododecane, Isohexadecane, Lauryl

PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl

Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20,

Saccharomyces/Selenium Ferment, Sambucus Nigra Flower

Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate,

Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Section 51945-4 (51945-4)

Principal Display Panel – 15 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

eye repair non-tinted

mineral sunscreen

broad spectrum spf 20 with

gentle zinc oxide, peptides

& botanical blend

net wt. 0.5 oz. / 15 g

Graphic-Untitled

Section 55105-1 (55105-1)

PURPOSE:Sunscreen

Section 55106-9 (55106-9)

ACTIVE INGREDIENT: Zinc Oxide 9%

Section 60561-8 (60561-8)

OTHER INFORMATION: • Protect this product from excessive

heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:38.321748 · Updated: 2026-03-14T23:03:49.531028