Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 2e53defe-98a3-4689-8763-35d76b5701c3
Route
TOPICAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (85.4 mg) Zinc Oxide (40.7 mg)
Inactive Ingredients
Aluminum Hydroxide Cyclomethicone 6 Cyclomethicone 5 Dimethicone 20 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Brown Iron Oxide Lauryl Peg/ppg-18/18 Methicone Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst) Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-05-21

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

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.

Warnings:

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

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply:

  • After 80 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 lime 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

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (Cl 77491), Lauryl PEG/ PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel 50 G Tube Label

TiZO ® 3

PRIMER/

SUNSCREEN

Tinted

SPF

40

PA+++

FACIAL

MINERAL SUNSCREEN

With Antioxidants C & E

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.75 Oz./50 g

Principal Display Panel 50 G Carton Label

TiZO ® 3

PRIMER/

SUNSCREEN

Tinted

SPF

40

PA+++

FACIAL

MINERAL SUNSCREEN

Titanium & Zinc Oxides

Antioxidants C & E

Sheer Matte Finish

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.75 Oz./50 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.

Purpose

Sunscreen

Sunscreen

Warnings:

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

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply:

  • After 80 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 lime 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

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (Cl 77491), Lauryl PEG/ PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel 50 G Tube Label (Principal Display Panel - 50 g Tube Label)

TiZO ® 3

PRIMER/

SUNSCREEN

Tinted

SPF

40

PA+++

FACIAL

MINERAL SUNSCREEN

With Antioxidants C & E

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.75 Oz./50 g

Principal Display Panel 50 G Carton Label (Principal Display Panel - 50 g Carton Label)

TiZO ® 3

PRIMER/

SUNSCREEN

Tinted

SPF

40

PA+++

FACIAL

MINERAL SUNSCREEN

Titanium & Zinc Oxides

Antioxidants C & E

Sheer Matte Finish

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.75 Oz./50 g


Advanced Ingredient Data


Raw Label Data

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