SPL v3
SPL
SPL Set ID e4a06973-21bb-4eda-9b74-fc23bee141ab
Route
TOPICAL
Published
Effective Date 2022-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-15

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

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 42229-5

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep out of the reach of children.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product, keep out of eyes. Rinse with water to remove.

Warnings:

For external use only. Do not use on damaged or broken skin.

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
Other Information:
  • Protect this product from excessive heat and direct sun
  • Shake well before use
Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C 12-15Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, 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

Principal Display Panel –100g Tube Label

TiZO ®

ULTRA ZINC

Non-Tinted

SPF

40

MINERAL SUNSCREEN

FOR BODY & FACE

With Antioxidants C & E

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 Oz./ 100g

Principal Display Panel –100g Carton Label

TiZO ®

ULTRA ZINC

Non-Tinted

SPF

40

MINERAL SUNSCREEN

FOR BODY & FACE

20% Zinc Oxide

Antioxidants C & E

Moisturizing

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 Oz./ 100g


Structured Label Content

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 42229-5 (42229-5)

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product, keep out of eyes. Rinse with water to remove.

Purpose

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin.

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
Other Information:
  • Protect this product from excessive heat and direct sun
  • Shake well before use
Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C 12-15Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, 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

Principal Display Panel –100g Tube Label

TiZO ®

ULTRA ZINC

Non-Tinted

SPF

40

MINERAL SUNSCREEN

FOR BODY & FACE

With Antioxidants C & E

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 Oz./ 100g

Principal Display Panel –100g Carton Label

TiZO ®

ULTRA ZINC

Non-Tinted

SPF

40

MINERAL SUNSCREEN

FOR BODY & FACE

20% Zinc Oxide

Antioxidants C & E

Moisturizing

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 Oz./ 100g


Advanced Ingredient Data


Raw Label Data

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