BIOMI ACTION DE GALA MINERAL SUNSCREEN SPF30: Package Insert and Label Information

BIOMI ACTION DE GALA MINERAL SUNSCREEN SPF30- titanium dioxide and zinc oxide cream
DECTRONIQUE (1984) INC

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

Titanium Dioxide 2.0%
Zinc Oxide 18.4%

Purpose

Sunscreen

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.

Warnings

For external use only

Do not use

on damaged or broken skin.

When using this product

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Directions

▪ Apply liberally and evenly 15 minutes before sun exposure ▪ Reapply ▪ After 80 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 10 a.m. — 2 p.m. ▪ Wear long-sleeved shirts, pants, hats, and sunglasses ▪ Use a water-resistant sunscreen if swimming or sweating.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

C10-18 Triglycerides, Sodium Citrate, Panax Ginseng Extract*, Tocopherol, Propanediol, Potassium Sorbate, Sodium Stearoyl Glutamate, Hyaluronate Sodium, Aloe Barbadensis Leaf Juice*, Coco-Caprylate, Alumina, Glycerin, Stearic Acid, Xanthan Gum, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Salicylic Acid, Benzyl Alcohol, Isostearic Acid, Sorbic Acid, Cetyl Alcohol, Caprylic/Capric/ Linoleic Triglyceride, Glyceryl Stearate.

*Certified Organic.

Questions or Comments?

1-800-463-5566
Outside Canada or the United States dial +1 418-650-0303 or visit www.dectro.com

BIOMI ACTION DE GALA SFP 30 MINERAL SUNSCREEN 50 mL (NDC 73626-050-00)

BIOMI ACTION DE GALA MINERAL SUNSCREEN SPF30 titanium dioxide, zinc oxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73626-050 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2 g in 100 mL ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 18.4 g in 100 mL

Inactive Ingredients Ingredient Name Strength CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE GLYCERYL STEARATE SE C10-18 TRIGLYCERIDES SODIUM CITRATE PANAX GINSENG ROOT OIL TOCOPHEROL PROPANEDIOL POTASSIUM SORBATE SODIUM STEAROYL GLUTAMATE HYALURONATE SODIUM ALOE VERA LEAF COCO-CAPRYLATE ALUMINUM OXIDE GLYCERIN STEARIC ACID XANTHAN GUM LECITHIN, SUNFLOWER POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-3 RICINOLEATE SALICYLIC ACID BENZYL ALCOHOL ISOSTEARIC ACID SORBIC ACID CETYL ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73626-050-01 1 TUBE in 1 BOX contains a TUBE (73626-050-00) 1 NDC:73626-050-00 50 mL in 1 TUBE This package is contained within the BOX (73626-050-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2020

Labeler — DECTRONIQUE (1984) INC (246237945)

Registrant — DECTRONIQUE (1984) INC (246237945)

Establishment
Name	Address	ID/FEI	Operations
LABORATOIRES DRUIDE INC		245815014	manufacture (73626-050)

Establishment
Name	Address	ID/FEI	Operations
DECTRONIQUE (1984) INC		246237945	pack (73626-050)

Revised: 03/2020 DECTRONIQUE (1984) INC