SPL v1
SPL
SPL Set ID 79441f57-7394-4873-a7f5-e405cd6e77e2
Route
TOPICAL
Published
Effective Date 2013-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (80 mg) Zinc Oxide (38 mg)
Inactive Ingredients
Aluminum Oxide Cyclomethicone 6 Cyclomethicone 5 Dimethicone 20 Dimethicone/diene Dimethicone Crosspolymer Dimethiconol (100000 Cst) Lauryl Peg/ppg-18/18 Methicone Methicone (20 Cst) Peg-10 Dimethicone (600 Cst)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-07-19

Description

DRUG FACTS

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

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.

Warnings:

For external use only.

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 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
Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cydopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone

Principal Display Panel – 1.5 Oz Carton Label

DERMATOLOGIST RECOMMENDED

CoTZ ®

FACE

The Healthier Sunscreen TM

Silky Soft

Sheer Matte Finish

Balanced Mineral ComplexTM Helps Prevent

Heat Build-Up in Skin, which can

Damage the Dermis

100% Free of:

Preservatives, Chemical Sunscreens, Oils

SPF 40

Broad

Spectrum

UVA-UVB

For Lighter

Skin Tones

Water Resistant

(80 minutes)

Net Wt. 1.5 oz/42.5 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

Sunscreen

Warnings:

For external use only.

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 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
Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cydopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone

Principal Display Panel – 1.5 Oz Carton Label (Principal Display Panel – 1.5 oz Carton Label)

DERMATOLOGIST RECOMMENDED

CoTZ ®

FACE

The Healthier Sunscreen TM

Silky Soft

Sheer Matte Finish

Balanced Mineral ComplexTM Helps Prevent

Heat Build-Up in Skin, which can

Damage the Dermis

100% Free of:

Preservatives, Chemical Sunscreens, Oils

SPF 40

Broad

Spectrum

UVA-UVB

For Lighter

Skin Tones

Water Resistant

(80 minutes)

Net Wt. 1.5 oz/42.5 g


Advanced Ingredient Data


Raw Label Data

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