DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (100 mg) Zinc Oxide (30 mg)

Inactive Ingredients

Butylene Glycol Butylparaben Medium-chain Triglycerides Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Cetostearyl Alcohol Cetearyl Glucoside Cyclomethicone Dimethicone Edetate Trisodium Glyceryl Monostearate Ferric Oxide Yellow Ferrosoferric Oxide Isobutylparaben Isopropylparaben Melissa Officinalis Leaf Octyldodecyl Neopentanoate Peg-100 Stearate Phenoxyethanol Vitamin A Palmitate Sorbitan Monolaurate Talc Tocopherol .alpha.-tocopherol Acetate Tricontanyl Povidone (4 Tricontanyl Branches/repeat) Water Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-01-03

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.

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 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 10%

Zinc Oxide 3%

Inactive Ingredients:

Acrylates C_10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Leaf Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

Principal Display Panel – 2.5 Oz Carton Label

DERMATOLOGIST RECOMMENDED

CoTZ ^®

PLUS

The Healthier Sunscreen ^TM

Balanced Mineral Complex™

#1 Rated UV Protection*

Will Not Irritate or Sting

Helps Prevent Heat Build-Up in Skin

which can Damage the Dermis

100% Free of:

Chemical Sunscreens & Oils

SPF 58 Broad

Spectrum

UVA-UVB

Blends

Translucent

Water

Resistant

(40 minutes)

Net Wt. 2.5 oz/70.0 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 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 10%

Zinc Oxide 3%

Inactive Ingredients:

Acrylates C_10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Leaf Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

Principal Display Panel – 2.5 Oz Carton Label (Principal Display Panel – 2.5 oz Carton Label)

DERMATOLOGIST RECOMMENDED

CoTZ ^®

PLUS

The Healthier Sunscreen ^TM

Balanced Mineral Complex™

#1 Rated UV Protection*

Will Not Irritate or Sting

Helps Prevent Heat Build-Up in Skin

which can Damage the Dermis

100% Free of:

Chemical Sunscreens & Oils

SPF 58 Broad

Spectrum

UVA-UVB

Blends

Translucent

Water

Resistant

(40 minutes)

Net Wt. 2.5 oz/70.0 g

Advanced Ingredient Data

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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glyceryl Monostearate", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Ferric Oxide Yellow", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Ferrosoferric Oxide", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Isobutylparaben", "unii": "0QQJ25X58G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Isopropylparaben", "unii": "A6EOX47QK0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Melissa Officinalis Leaf", "unii": "50D2ZE9219", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Octyldodecyl Neopentanoate", "unii": "X8725R883T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 Stearate", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Phenoxyethanol", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Vitamin A Palmitate", "unii": "1D1K0N0VVC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbitan Monolaurate", "unii": "6W9PS8B71J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Talc", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Tocopherol", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".Alpha.-Tocopherol Acetate", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Tricontanyl Povidone (4 Tricontanyl Branches/Repeat)", "unii": "N0SS3Q238D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Xanthan Gum", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "42229-5": "DRUG FACTS", "50565-1": "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs.", "50567-7": "When using this product, keep out of eyes. Rinse with water to remove.", "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 40 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 10% Zinc Oxide 3%", "Inactive Ingredients:": "Acrylates C 10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Leaf Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum", "Principal Display Panel – 2.5 oz Carton Label": "DERMATOLOGIST RECOMMENDED CoTZ ® PLUS The Healthier Sunscreen TM Balanced Mineral Complex™ #1 Rated UV Protection* Will Not Irritate or Sting Helps Prevent Heat Build-Up in Skin which can Damage the Dermis 100% Free of: Chemical Sunscreens & Oils SPF 58 Broad Spectrum UVA-UVB Blends Translucent Water Resistant (40 minutes) Net Wt. 2.5 oz/70.0 g"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information