BIOMI ACTION DE GALA SFP 30 MINERAL SUNSCREEN 50 mL

BIOMI ACTION DE GALA MINERAL SUNSCREEN by

Drug Labeling and Warnings

BIOMI ACTION DE GALA MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES DRUIDE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOMI ACTION DE GALA MINERAL SUNSCREEN SPF30- titanium dioxide, zinc oxide cream 
LABORATOIRES DRUIDE 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.

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BIOMI ACTION DE GALA SFP 30 MINERAL SUNSCREEN 50 mL

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: 71447-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO-CAPRYLATE (UNII: 4828G836N6)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ISOSTEARIC ACID (UNII: X33R8U0062)
SORBIC ACID (UNII: X045WJ989B)
CETYL ALCOHOL (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-050-01	1 in 1 BOX	03/01/2020
1	NDC: 71447-050-00	50 mL in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - LABORATOIRES DRUIDE INC (245815014)

Registrant - LABORATOIRES DRUIDE INC (245815014)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-050)

Revised: 3/2021

Document Id: d381dc02-015f-ee0d-e053-2995a90a3d39

34390-5

Set id: d381e8b5-44a5-514b-e053-2a95a90aa072

Version: 1

Effective Time: 20210301