FDA.reportPublic FDA data

BIOMI ACTION DE GALA MINERAL SUNSCREEN

Manufacturer
LABORATOIRES DRUIDE INC
Effective date
2021-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:22:08

Label at a glance#

ProductBIOMI ACTION DE GALA MINERAL SUNSCREEN SPF30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections

Indications and 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.

Dosage and administration

▪ 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 inclu...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2.0%



Zinc Oxide 18.4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

▪ 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION





▪ 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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOMI ACTION DE GALA SFP 30 MINERAL SUNSCREEN 50 mLBIOMI ACTION DE GALA SFP 30 MINERAL SUNSCREEN 50 mL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71447-05071447-050-00, 71447-050-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDEU73D397055IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
SODIUM CITRATE1Q73Q2JULRIACT
PANAX GINSENG ROOT OILP9T4K47OM0IACT
TOCOPHEROLR0ZB2556P8IACT
PROPANEDIOL5965N8W85TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCO-CAPRYLATE4828G836N6IACT
ALUMINUM OXIDELMI26O6933IACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
SALICYLIC ACIDO414PZ4LPZIACT
BENZYL ALCOHOLLKG8494WBHIACT
ISOSTEARIC ACIDX33R8U0062IACT
SORBIC ACIDX045WJ989BIACT
CETYL ALCOHOL936JST6JCNIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d381dc02-015f-ee0d-e053-2995a90a3d39d381e8b5-44a5-514b-e053-2a95a90aa0722021-03-01WarningsExact identifier
spl id: d381dc02-015f-ee0d-e053-2995a90a3d39
spl set id: d381e8b5-44a5-514b-e053-2a95a90aa072

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.