Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5cf0d2e3-d496-424c-ac75-70ff5b87e9ca
Route
TOPICAL
Published
Effective Date 2024-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (100 mg) Zinc Oxide (30 mg)
Inactive Ingredients
Bismuth Oxychloride Medium-chain Triglycerides Caprylhydroxamic Acid Caprylyl Glycol Polyoxyl 20 Cetostearyl Ether Cyclomethicone 6 Cyclomethicone 5 Dimethicone Edetate Disodium Anhydrous Ethylhexyl Hydroxystearate Benzoate Glycerin Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Isododecane Isohexadecane Melissa Officinalis Whole Mica Microcrystalline Wax Octyldodecyl Neopentanoate Peg-30 Dipolyhydroxystearate (4000 Mw) Sodium Chloride Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Tocopherol Trolamine Triethoxycaprylylsilane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-25
Description

Titanium Dioxide 10% Zinc Oxide 3%

Purpose

Sunscreen Sunscreen

Medication Information

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 10% Zinc Oxide 3%

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.

Purpose:

Sunscreen

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin.

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 am-2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

MANUFACTURED FOR:

Kathleeen Hutton MD

Newport Beach, CA 92660

WWW.HUTTONKLEIN.COM

800-909-0060

Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Inactive Ingredients:

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel – 53 G Bottle Label

HUTTON KLEIN

HK

DERMATOLOGISTS

SPF 50

Mineral Based

Facial Sunscreen

  • Free of Chemical Sunscreens
  • Water-Resistant (40 Minutes)
  • Broad Spectrum
  • Oil and PABA Free

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.

Purpose: (PURPOSE:)

Sunscreen

Sunscreen

Warnings: (WARNINGS:)

For external use only. Do not use on damaged or broken skin.

Directions: (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 am-2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information: (OTHER INFORMATION:)
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

MANUFACTURED FOR:

Kathleeen Hutton MD

Newport Beach, CA 92660

WWW.HUTTONKLEIN.COM

800-909-0060

Active Ingredients: (ACTIVE INGREDIENTS:)

Titanium Dioxide 10%

Zinc Oxide 3%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

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

HUTTON KLEIN

HK

DERMATOLOGISTS

SPF 50

Mineral Based

Facial Sunscreen

  • Free of Chemical Sunscreens
  • Water-Resistant (40 Minutes)
  • Broad Spectrum
  • Oil and PABA Free

Net. Wt. 1.8 oz./ 53 g

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:54.793311 · Updated: 2026-03-14T23:02:42.365017