Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 0973223b-e75f-4eb8-bcf1-7931b30b7b51
Route
TOPICAL
Published
Effective Date 2021-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Bismuth Oxychloride 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 Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Hydrogen Dimethicone (20 Cst) Mica 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 2015-01-01

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 50565-1

Keep out of the 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 the 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 sin, especially from 10 am-2 p.m.
    • 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:

Zinc Oxide 20%

Inactive Ingredients:

Bismuth Oxychloride, C 12-15Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20. Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel Cotz Flawless Complexion Tube Label

CoTZ ®

the

HEALTHIER

SUNSCREEN ®

Flawless

Complexion

Tinted

SPF

50

Vanishing Zinc Oxide

MINERAL SUNSCREEN

FACE

Broad Spectrum SPF 50

Net Wt. 2.5 oz/70 g

Principal Display Panel Cotz Flawless Complexion Carton Label

CoTZ ®

the

HEALTHIER

SUNSCREEN ®

Flawless

Complexion

Tinted

SPF

50

Vanishing Zinc Oxide

MINERAL SUNSCREEN

FACE

Broad Spectrum SPF 50

Net Wt. 2.5 oz/70 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.

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 the 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 sin, especially from 10 am-2 p.m.
    • 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:

Zinc Oxide 20%

Inactive Ingredients:

Bismuth Oxychloride, C 12-15Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20. Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel Cotz Flawless Complexion Tube Label (Principal Display Panel - Cotz Flawless Complexion Tube Label)

CoTZ ®

the

HEALTHIER

SUNSCREEN ®

Flawless

Complexion

Tinted

SPF

50

Vanishing Zinc Oxide

MINERAL SUNSCREEN

FACE

Broad Spectrum SPF 50

Net Wt. 2.5 oz/70 g

Principal Display Panel Cotz Flawless Complexion Carton Label (Principal Display Panel - Cotz Flawless Complexion Carton Label)

CoTZ ®

the

HEALTHIER

SUNSCREEN ®

Flawless

Complexion

Tinted

SPF

50

Vanishing Zinc Oxide

MINERAL SUNSCREEN

FACE

Broad Spectrum SPF 50

Net Wt. 2.5 oz/70 g


Advanced Ingredient Data


Raw Label Data

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