Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6
Route
TOPICAL
Published
Effective Date 2019-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg)
Inactive Ingredients
Medium-chain Triglycerides Ceramide Np Cyclomethicone 6 Cyclomethicone 5 Dimethicone 20 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst) Polyhydroxystearic Acid (2300 Mw) Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-05

Description

Zinc Oxide 16%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 16%

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 16%

Inactive Ingredients:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

Principal Display Panel – Tube Label

TIZO ®

PHOTOCEUTICAL

AM

REPLENISH

Non-Tinted

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY ®

SPF 40

Broad Spectrum

1.75 Fl. Oz/50 mL

Principal Display Panel – Carton Label

AM

REPLENISH

Non-Tinted

SPF 40

TIZO ®

PHOTOCEUTICAL ®

Enhances, protects &

neutralizes free radicals

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY ®

Broad Spectrum SPF 40

Net Wt. 1.75 oz/50 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 16%

Inactive Ingredients:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

Principal Display Panel – Tube Label

TIZO ®

PHOTOCEUTICAL

AM

REPLENISH

Non-Tinted

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY ®

SPF 40

Broad Spectrum

1.75 Fl. Oz/50 mL

Principal Display Panel – Carton Label

AM

REPLENISH

Non-Tinted

SPF 40

TIZO ®

PHOTOCEUTICAL ®

Enhances, protects &

neutralizes free radicals

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY ®

Broad Spectrum SPF 40

Net Wt. 1.75 oz/50 g


Advanced Ingredient Data


Raw Label Data

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