FDA.reportPublic FDA data

Britto Facial Sunscreen Broad Spectrum SPF 50

Manufacturer
MR2 USA Corporation | COSMODERMA INDUSTRIA E COMERCIO LTDA
Effective date
2020-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:56

Label at a glance#

ProductBritto Facial Sunscreen Broad Spectrum SPF 50
Active ingredientOCTINOXATE, OXYBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure10 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 ageing caused by the sun

Dosage and administration

Apply liberally 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: · lim...

Storage and handling

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

Label contents#

Full prescribing information#

Principal Display Panel - Statement of identity

STATEMENT OF IDENTITY SECTION

Britto Facial Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)

Drug Facts Panel - Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00% ----- Sunscreen

Homosalate 15.00% ----- Sunscreen

Octinoxate 7.50% ----- Sunscreen

Octisalate 5.00% ----- Sunscreen

Octocrylene 10.00% ---- Sunscreen

Oxybenzone 6.00% ----- Sunscreen

Drug Facts Panel - Purpose

OTC - PURPOSE SECTION

Purpose: sunscreen

Drug Facts Panel - 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 ageing caused by the sun

Drug Facts Panel - Warnings

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin.

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts Panel - Directions

INSTRUCTIONS FOR USE SECTION

  • Apply liberally 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 10 a.m.-2 p.m. · wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: ask a doctor.

Drug Facts Panel - Other information

STORAGE AND HANDLING SECTION

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

Drug Facts Panel - Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alpha-Tocopherol Acetate, Butylated Hydroxytoluene, Ethylhexyl Stearate, Fragrance, Glycerin, Glyceryl Dipalmitate, Glyceryl Distearate, Glyceryl Palmitate, Glyceryl Stearate, Hydrolyzed Collagen, Methylparaben, Neopentyl Glycol Diheptanoate, Polyester-7, Potassium Cetyl Phosphate, Potassium Stearate, Propylene Glycol, Propylparaben, Stearic Acid, Tetrasodium EDTA, Water, Xanthan Gum.

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments? Contact weekdays from 9AM to 5PM at 1-305-646-1169.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 ml NDC 77069-003-01

Label 50 mlLabel 50 ml

100 ml NDC 77069-003-02

Label 100 mlLabel 100 ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77069-003-012022-01-28C16284748780-1d6a99b39-cf04-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION
77069-003-022022-01-28C16284748780-1d6a99b39-cf04-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77069-003-01Britto Facial Sunscreen Broad Spectrum SPF 5050 mL in 1 TUBECREAM502
77069-003-02Britto Facial Sunscreen Broad Spectrum SPF 50100 mL in 1 TUBECREAM1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77069-003BRITTO FACIAL SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MR2 USA CORPORATION]2Legacy NDC, 2 package rows20201228_a4e8e4ff-5eb0-e102-e053-2a95a90ae971.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77069-00377069-003-01, 77069-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE SODIUMMP1J8420LUIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
POTASSIUM STEARATE17V812XK50IACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GLYCERYL DISTEARATE73071MW2KMIACT
GLYCERYL PALMITATE6Y2XJ05B35IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
STEARIC ACID4ELV7Z65APIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERYL DIPALMITATE7775E5IR3LIACT
GLYCERINPDC6A3C0OXIACT
PORK COLLAGENI8442U2G7JIACT

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
b77c3d44-2e47-5429-e053-2995a90ad933a4e8e4ff-5eb0-e102-e053-2a95a90ae9712020-12-27WarningsExact identifier
spl id: b77c3d44-2e47-5429-e053-2995a90ad933
spl set id: a4e8e4ff-5eb0-e102-e053-2a95a90ae971

Reported adverse events (FAERS/openFDA)#

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