Ozone Face Protection Daily Moisturizer by Human Race PW LLC Face SPF

Ozone Face Protection Daily Moisturizer by

Drug Labeling and Warnings

Ozone Face Protection Daily Moisturizer by is a Otc medication manufactured, distributed, or labeled by Human Race PW LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OZONE FACE PROTECTION DAILY MOISTURIZER- zinc oxide cream 
Human Race PW LLC

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Face SPF

Drug Facts

Active Ingredients Purpose

Zinc Oxide, 15%................................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 at least evert 2 hours Use a water resistet sunscreen if swimming or sweating 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, Caprylic/Capric Triglyceride, Glycerin, Squalane, Glyceryl Stearate Se, Cetearyl Alcohol, Pentylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Propanediol, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Extract, Betaine, Caesalpinia Spinosa Fruit Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Cetearyl Glucoside, Erythritol, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Sprout Extract, Hibiscus Sabdariffa Fruit Extract, Maltodextrin, 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 at least evert 2 hours Use a water resistet sunscreen if swimming or sweating 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

Other information

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

Inactive Ingredients

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

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OZONE FACE PROTECTION DAILY MOISTURIZER 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82779-001
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
SQUALANE (UNII: GW89575KF9)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ERYTHRITOL (UNII: RA96B954X6)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
JOJOBA OIL (UNII: 724GKU717M)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BETAINE (UNII: 3SCV180C9W)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
GLYCERIN (UNII: PDC6A3C0OX)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
WATER (UNII: 059QF0KO0R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82779-001-011 in 1 CARTON06/10/2022
153 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 - Human Race PW LLC (117759858)

Revised: 1/2024
 

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