Ozone Body Protection Cream

Manufacturer
Humanrace
Effective date
2022-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:57:06

Label at a glance#

ProductOzone Body Protection Cream
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

Uses • Helps prevent sunburn.

Dosage and administration

Directions • Apply liberally and evenly 15 minutes before sun exposure • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 meas...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide, 15%

Purpose

Sunscreen

Uses• Helps prevent sunburn.

Warnings• For external use only • Do not use on damaged or broken skin. • When using this product keep out of eyes. Rinse with water to remove. • Stop use and ask a doctor if rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions• Apply liberally and evenly 15 minutes before sun exposure • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 10am- 2pm • Wear long sleeved shirts, plants, hats, and sunglasses • Children under 6 months: ask a doctor

Inactive Ingredients• Aqua/Water/Eau, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Glyceryl Stearate Se, Simmondsia Chinensis (Jojoba) Seed Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Pentylene Glycol, Propanediol, Polyhydroxystearic Acid, Squalane, Aloe Barbadensis Leaf Extract, Betaine, Caprylhydroxamic Acid, Caprylyl Glycol, Cetearyl Glucoside, Glyceryl Caprylate, Glyceryl Undecylenate, Pongamia Pinnata Seed Extract, Sodium Hydroxide, Sodium Stearoyl Glutamate, Sorbitan Stearate, Tetrasodium Glutamate Diacetate, Tocopherol, Tremella Fuciformis Sporocarp (Snow Mushroom) Extract, Xanthan Gum.

Other Information • Protect this product from excessive heat and direct sun.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Zinc Oxide, 15%

Purpose

OTC - PURPOSE SECTION

Purpose

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Uses • Helps prevent sunburn.

Warnings

WARNINGS SECTION

Warnings • For external use only • Do not use on damaged or broken skin. • When using this product keep out of eyes. Rinse with water to remove. • Stop use and ask a doctor if rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions • Apply liberally and evenly 15 minutes before sun exposure • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 10am- 2pm • Wear long sleeved shirts, plants, hats, and sunglasses • Children under 6 months: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients • Aqua/Water/Eau, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Glyceryl Stearate Se, Simmondsia Chinensis (Jojoba) Seed Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Pentylene Glycol, Propanediol, Polyhydroxystearic Acid, Squalane, Aloe Barbadensis Leaf Extract, Betaine, Caprylhydroxamic Acid, Caprylyl Glycol, Cetearyl Glucoside, Glyceryl Caprylate, Glyceryl Undecylenate, Pongamia Pinnata Seed Extract, Sodium Hydroxide, Sodium Stearoyl Glutamate, Sorbitan Stearate, Tetrasodium Glutamate Diacetate, Tocopherol, Tremella Fuciformis Sporocarp (Snow Mushroom) Extract, Xanthan Gum.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

side panel 2 bodyside panel 2 bodyside panel 1 bodyside panel 1 bodydrug facts bodydrug facts bodybody frontbody front

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82779-00282779-002-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ea1e237-a61b-42cf-e063-6394a90a1a0de11c6949-c1ad-69db-e053-2995a90a8e8f2024-01-10WarningsExact identifier
spl set id: e11c6949-c1ad-69db-e053-2995a90a8e8f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.