Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (80 mg) Zinc Oxide (38 mg)

Inactive Ingredients

Aluminum Hydroxide Cyclomethicone 6 Cyclomethicone 5 Dimethicone 20 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Brown Iron Oxide Lauryl Peg/ppg-18/18 Methicone Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst) Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-02-17

Medication Information

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

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. 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 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Children under 6 months: Ask a doctor

Other Information:

Protect this product from excessive heat and direct sun
May stain some fabrics
Cleanse thoroughly at nighttime
PA+++

MANUFACTURED FOR:

Kathleeen Hutton MD

Newport Beach, CA 92660

WWW.HUTTONKLEIN.COM

800-909-0060

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18-Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

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 am-2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses

Principal Display Panel – 53 G Bottle Label

HUTTON KLEIN

HK

DERMATOLOGISTS

SPF 40

Mineral Based

Facial Sunscreen

Free of Chemical Sunscreens
Water-Resistant (80 Minutes)
Broad Spectrum
Unscented
Oil and PABA Free

Tinted

Net. Wt. 1.8 oz./ 53 g

Structured Label Content

Uses: (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. 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: (PURPOSE:)

Sunscreen

Warnings: (WARNINGS:)

For external use only.

Directions: (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

Other Information: (OTHER INFORMATION:)

Protect this product from excessive heat and direct sun
May stain some fabrics
Cleanse thoroughly at nighttime
PA+++

MANUFACTURED FOR:

Kathleeen Hutton MD

Newport Beach, CA 92660

WWW.HUTTONKLEIN.COM

800-909-0060

Active Ingredients: (ACTIVE INGREDIENTS:)

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18-Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

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 am-2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses

Principal Display Panel – 53 G Bottle Label (Principal Display Panel – 53 g Bottle Label)

HUTTON KLEIN

HK

DERMATOLOGISTS

SPF 40

Mineral Based

Facial Sunscreen

Free of Chemical Sunscreens
Water-Resistant (80 Minutes)
Broad Spectrum
Unscented
Oil and PABA Free

Tinted

Net. Wt. 1.8 oz./ 53 g

Advanced Ingredient Data

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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.", "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 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor", "OTHER INFORMATION:": "Protect this product from excessive heat and direct sun May stain some fabrics Cleanse thoroughly at nighttime PA+++ MANUFACTURED FOR: Kathleeen Hutton MD Newport Beach, CA 92660 WWW.HUTTONKLEIN.COM 800-909-0060", "ACTIVE INGREDIENTS:": "Titanium Dioxide 8% Zinc Oxide 3.8%", "INACTIVE INGREDIENTS:": "Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18-Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate", "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 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses", "Principal Display Panel – 53 g Bottle Label": "HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Free of Chemical Sunscreens Water-Resistant (80 Minutes) Broad Spectrum Unscented Oil and PABA Free Tinted Net. Wt. 1.8 oz./ 53 g"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information