SPL v5
SPL
SPL Set ID ddd4ea96-e305-4d66-9341-739663f381b5
Route
TOPICAL
Published
Effective Date 2020-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (30 mg) Zinc Oxide (100 mg)
Inactive Ingredients
Bismuth Oxychloride Butyloctyl Salicylate Alkyl (c12-15) Benzoate Caprylhydroxamic Acid Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Form Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Citric Acid Monohydrate Edetate Disodium Anhydrous Glycereth-26 Glycerin Glyceryl Monostearate Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Isododecane Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Mica Microcrystalline Cellulose Octyldodecyl Erucate Octyldodecyl Neopentanoate Behenyl Acrylate Polymer Polyhydroxystearic Acid (2300 Mw) Poly(methyl Methacrylate; 450000 Mw) Polysorbate 80 1,3,3,3-tetrafluoropropene, (1e)- Tricontanyl Povidone Triethoxycaprylylsilane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-20

Description

Titanium Dioxide 3% Zinc Oxide 10%

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Description

Titanium Dioxide 3% Zinc Oxide 10%

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 50565-1

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

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.

Section 50570-1

Do not use on damaged or broken skin.

Warnings:

For external use only.

Directions:

Shake well before using. Use caution during first application. 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
  • May stain some fabrics
  • Store between 68° to 104° F (20° to 40°C)
  • Do not store at temperatures above 120° F
Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

Inactive Ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum. Ceteareth-20, Cetearyl Alcohol. Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Mica. Macrocrystalline Cellulose, Octyldodecyl Erucate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid. Polysorbate 80, Trans-1,3,3,3- Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Principal Display Panel – 100g Can Label

MINERAL

PROTECTION

TIZO ®

SHEERFOAM™

TINTED

SPF 30

Mineral Sunscreen

For Body & Face

Titanium & Zinc Oxides

Weightless

Spreads Easily

Broad Spectrum SPF 30

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – 1 Can Carton Label

TiZO ®

SHEERFOAM™

Tinted

SPF

30

MINERAL SUNSCREEN

FOR BODY & FACE

Titanium & Zinc Oxides

Weightless

Spreads Easily

Broad Spectrum SPF 30

Water Resistant (40 minutes)

Net Wt. 3.5 Oz/100 g


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 50565-1 (50565-1)

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

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.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Sunscreen

Warnings:

For external use only.

Directions:

Shake well before using. Use caution during first application. 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
  • May stain some fabrics
  • Store between 68° to 104° F (20° to 40°C)
  • Do not store at temperatures above 120° F
Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

Inactive Ingredients: (Inactive ingredients:)

Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum. Ceteareth-20, Cetearyl Alcohol. Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Mica. Macrocrystalline Cellulose, Octyldodecyl Erucate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid. Polysorbate 80, Trans-1,3,3,3- Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Principal Display Panel – 100g Can Label

MINERAL

PROTECTION

TIZO ®

SHEERFOAM™

TINTED

SPF 30

Mineral Sunscreen

For Body & Face

Titanium & Zinc Oxides

Weightless

Spreads Easily

Broad Spectrum SPF 30

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – 1 Can Carton Label

TiZO ®

SHEERFOAM™

Tinted

SPF

30

MINERAL SUNSCREEN

FOR BODY & FACE

Titanium & Zinc Oxides

Weightless

Spreads Easily

Broad Spectrum SPF 30

Water Resistant (40 minutes)

Net Wt. 3.5 Oz/100 g


Advanced Ingredient Data


Raw Label Data

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