SPL v3
SPL
SPL Set ID 33f8760c-2953-44a6-9239-424fdb97a5b3
Route
TOPICAL
Published
Effective Date 2020-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-01
Description

Zinc Oxide 9%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 9%

Uses:

Helps prevents 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 50565-1

Keep out of reach of children.

Purpose:

Sunscreen

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.

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 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information:
  • Protect this product from excessive heat and direct sun.
Active Ingredients:

Zinc Oxide 9%

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 Hydrogen Dimethicone,PaImitoyI Tripeptide-1, PaImitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomy- ces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Principal Display Panel 100 G Carton Label

MINERAL

PROTECTION

TIZO ®

EYE RENEWAL

NON-TINTED

SPF 20

Firming Eye Repair

Mineral Sunscreen

Gentle Zinc Oxide

Peptides

Botanical Blend

Broad Spectrum SPF 20

Net Wt. 0.5 oz/15 g

Structured Label Content

Uses:

Helps prevents 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 50565-1 (50565-1)

Keep out of reach of children.

Purpose:

Sunscreen

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.

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 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information:
  • Protect this product from excessive heat and direct sun.
Active Ingredients:

Zinc Oxide 9%

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 Hydrogen Dimethicone,PaImitoyI Tripeptide-1, PaImitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomy- ces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Principal Display Panel 100 G Carton Label (Principal Display Panel - 100 g Carton Label)

MINERAL

PROTECTION

TIZO ®

EYE RENEWAL

NON-TINTED

SPF 20

Firming Eye Repair

Mineral Sunscreen

Gentle Zinc Oxide

Peptides

Botanical Blend

Broad Spectrum SPF 20

Net Wt. 0.5 oz/15 g

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.054424 · Updated: 2026-03-14T23:04:13.637753