SPL v2
SPL
SPL Set ID fd6d0080-0bef-4e7e-8ca5-b859639efd0c
Route
TOPICAL
Published
Effective Date 2022-08-23
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 Ethylene Brassylate 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 2022-04-01
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.

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 80 minutes of swimming or sweating
  • Immediately after towel drying
  • 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
Active Ingredients:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, EthylhexI Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Principal Display Panel – 30 G Carton Label

TiZO®

MINERAL STICK

Tinted

MINERAL SUNSCREEN

FOR BODY & FACE

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 1 Oz./30 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.

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 80 minutes of swimming or sweating
  • Immediately after towel drying
  • 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
Active Ingredients:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, EthylhexI Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Principal Display Panel – 30 G Carton Label (Principal Display Panel – 30 g Carton Label)

TiZO®

MINERAL STICK

Tinted

MINERAL SUNSCREEN

FOR BODY & FACE

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 1 Oz./30 g

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:03.049696 · Updated: 2026-03-14T23:04:28.287489