Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2be51fdf-c3f2-463b-8c7d-bda07db17e1b
Route
TOPICAL
Published
Effective Date 2023-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (40 mg) Zinc Oxide (55 mg)
Inactive Ingredients
Aluminum Oxide Aluminum Hydroxide Aluminum Stearate Ascorbic Acid Ascorbyl Palmitate Alkyl (c12-15) Benzoate Cetearyl Isononanoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Citric Acid Monohydrate Dipropylene Glycol Caprylate Ethylhexyl Palmitate Citrus Aurantiifolia Fruit Oil Kiwi Fruit Oil Helianthus Annuus Seed Wax Hexyldecanol Hexyl Laurate Ferric Oxide Red Lecithin, Sunflower Ceresin Polyethylene Glycol 400 Polyglyceryl-3 Diisostearate Polyhydroxystearic Acid (2300 Mw) Stearic Acid Tocopherol .alpha.-tocopherol Acetate Ginger Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-17
Description

Titanium Dioxide 4.0% Zinc Oxide 5.5%

Purpose

Sunscreen Sunscreen

Medication Information

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 4.0% Zinc Oxide 5.5%

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

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 10:00 a.m.-2:00 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

Not tested on animals

Active Ingredients:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Principal Display Panel – 4.5 G Tube Label

HUTTON KLEIN

HK

DERMATOLOGISTS

Mineral Lip

Sunscreen

SPF 45

broad spectrum

water resistant

(80 mins)

Tinted

Net. Wt. .14 oz./ 4.5 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 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 10:00 a.m.-2:00 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

Not tested on animals

Active Ingredients:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Principal Display Panel – 4.5 G Tube Label (Principal Display Panel – 4.5 g Tube Label)

HUTTON KLEIN

HK

DERMATOLOGISTS

Mineral Lip

Sunscreen

SPF 45

broad spectrum

water resistant

(80 mins)

Tinted

Net. Wt. .14 oz./ 4.5 g

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.221539 · Updated: 2026-03-14T23:07:03.829205