17cc12c7-5af8-413f-b205-31ac150583e2

SPL v3
SPL
SPL Set ID 17cc12c7-5af8-413f-b205-31ac150583e2
Route
topical
Published
Effective Date 2019-11-12
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 2019-01-02

Purpose

Sunscreen

Description

DRUG FACTS


Medication Information

Purpose

Sunscreen

Description

DRUG FACTS

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

DRUG FACTS

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.

Purpose:

Sunscreen

Warnings:

For external use only.

Directions:
  • Apply liberally 15 minutes before sun exposure.

    Reapply:

    • -
      After 40 minutes of swimming or sweating
    • -
      Immediately after towel drying
    • -
      At least every two 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.
  • May stain some fabrics.

Manufactured Exclusively For:

CoTZ® Skincare

Norristown, PA 19403

www.cotzskincare.com

Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl 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 Dimethicome, PEG-30 Dipoly-hydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel – Cotz Baby Tube Label

CoTZ®

the HEALTHIER

SUNSCREEN®

Baby

Non-Tinted

SPF

40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Cotz Baby Carton Label

CoTZ®

the HEALTHIER

SUNSCREEN®

Baby

Non-Tinted

SPF

40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

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 42229-5 (42229-5)

DRUG FACTS

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

Warnings:

For external use only.

Directions:
  • Apply liberally 15 minutes before sun exposure.

    Reapply:

    • -
      After 40 minutes of swimming or sweating
    • -
      Immediately after towel drying
    • -
      At least every two 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.
  • May stain some fabrics.

Manufactured Exclusively For:

CoTZ® Skincare

Norristown, PA 19403

www.cotzskincare.com

Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl 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 Dimethicome, PEG-30 Dipoly-hydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel – Cotz Baby Tube Label (Principal Display Panel – CoTZ Baby Tube Label)

CoTZ®

the HEALTHIER

SUNSCREEN®

Baby

Non-Tinted

SPF

40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Cotz Baby Carton Label (Principal Display Panel – CoTZ Baby Carton Label)

CoTZ®

the HEALTHIER

SUNSCREEN®

Baby

Non-Tinted

SPF

40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g


Advanced Ingredient Data


Raw Label Data

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