Ozone Body Protection Cream by Humanrace SPF Body

Ozone Body Protection Cream by

Drug Labeling and Warnings

Ozone Body Protection Cream by is a Otc medication manufactured, distributed, or labeled by Humanrace. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OZONE BODY PROTECTION CREAM- zinc oxide cream 
Humanrace

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SPF Body

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

Active Ingredients

Zinc Oxide, 15%

Purpose

Purpose

Sunscreen

Uses

Uses Helps prevent sunburn.

Warnings

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

Do not use on damaged or broken skin.

Stop use

Stop use and ask a doctor if rash occurs.

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

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

Directions

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 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.

side panel 2 bodyside panel 1 bodydrug facts bodybody front

OZONE BODY PROTECTION CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82779-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
BETAINE (UNII: 3SCV180C9W)  
JOJOBA OIL (UNII: 724GKU717M)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
SQUALANE (UNII: GW89575KF9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82779-002-021 in 1 CARTON06/10/2022
1148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/10/202208/18/2023
Labeler - Humanrace (117759858)

Revised: 1/2024

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