OTC Medication Information: Ozone Body Protection Cream

OZONE BODY PROTECTION CREAM- zinc oxide cream
Humanrace

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

OZONE BODY PROTECTION CREAM zinc oxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82779-002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 g in 100 mL

Inactive Ingredients Ingredient Name Strength POLYHYDROXYSTEARIC ACID (2300 MW) PROPANEDIOL WATER SUNFLOWER OIL SODIUM HYDROXIDE CAPRYLYL GLYCOL CETEARYL GLUCOSIDE GLYCERYL CAPRYLATE TREMELLA FUCIFORMIS FRUITING BODY BETAINE JOJOBA OIL GLYCERYL 1-UNDECYLENATE TETRASODIUM GLUTAMATE DIACETATE CAPRYLHYDROXAMIC ACID GLYCERIN GLYCERYL STEARATE SE CETOSTEARYL ALCOHOL PONGAMIA PINNATA SEED SQUALANE ALOE VERA LEAF TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES PENTYLENE GLYCOL SODIUM STEAROYL GLUTAMATE SORBITAN MONOSTEARATE XANTHAN GUM CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82779-002-02 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP 1 148 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (82779-002-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/10/2022

Labeler — Humanrace (117759858)

Revised: 06/2022 Humanrace