FDA.reportPublic FDA data

Britto Body 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 23:35:57

Label at a glance#

ProductBritto Body Sunscreen Broad Spectrum SPF 50
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE, OXYBENZONE, HOMOSALATE, OCTINOXATE
Label structure10 sections

Label contents#

Full prescribing information#

Principal Display Panel - Statement of Identity

STATEMENT OF IDENTITY SECTION

PDP - Britto Body Sunscreen SPF50_100ml_REV01.jpgPDP - Britto Body Sunscreen SPF50_100ml_REV01.jpg

Drug Facts Panel - Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Labelling - Britto Body Sunscreen SPF50_100ml_REV01_Labelling - Britto Body Sunscreen SPF50_100ml_REV01_

Drug Facts Panel - Purpose

OTC - PURPOSE SECTION

Labelling - Britto Body Sunscreen SPF50_100ml_REV01Labelling - Britto Body Sunscreen SPF50_100ml_REV01

Drug Facts Panel - Uses

INDICATIONS & USAGE SECTION

Labelling - Britto Body Sunscreen SPF50_100ml_REV01_.jpgLabelling - Britto Body Sunscreen SPF50_100ml_REV01_.jpg

Drug Facts Panel - Warnings

WARNINGS SECTION

Labelling - Britto Body Sunscreen SPF50_100mlLabelling - Britto Body Sunscreen SPF50_100ml

Drug Facts Panel - Warnings - Do not use

OTC - DO NOT USE SECTION

Warnings - Do Not UseWarnings - Do Not Use

Drug Facts Panel - Warnings - Stop use

OTC - STOP USE SECTION

Warnings - Stop UseWarnings - Stop Use

Drug Facts Panel - Warnings - Ask a doctor

OTC - ASK DOCTOR SECTION

Warnings - Stop Use and Ask a DoctorWarnings - Stop Use and Ask a Doctor

Drug Facts Panel - Warnings - When using this product

OTC - WHEN USING SECTION

Warnings - When usingWarnings - When using

Drug Facts Panel - Warnings - Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings - Keep out of reach of childrenWarnings - Keep out of reach of children

Drug Facts Panel - Directions

INSTRUCTIONS FOR USE SECTION

DirectionsDirections

Durg Facts Panel - Other Information

STORAGE AND HANDLING SECTION

Other InformationOther Information

Drug Facts Panel - Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

Questions and reporting of adverse events

OTC - QUESTIONS SECTION

Questions or commentsQuestions or comments

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP - Britto Body Sunscreen SPF50_100ml_REV01PDP - Britto Body Sunscreen SPF50_100ml_REV01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77069-002-012022-01-28C16284748780-1d6a99b3a-01a6-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION
77069-002-022022-01-28C16284748780-1d6a99b3a-01a6-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77069-002-01Britto Body Sunscreen Broad Spectrum SPF 50100 mL in 1 TUBECREAM1002
77069-002-02Britto Body Sunscreen Broad Spectrum SPF 50200 mL in 1 TUBECREAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77069-002BRITTO BODY SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [MR2 USA CORPORATION]2Legacy NDC, 2 package rows20201228_a92d6720-aabf-a168-e053-2a95a90a4172.zip

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
77069-00277069-002-01, 77069-002-02

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

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
b77c5598-1da6-198b-e053-2a95a90a3385a92d6720-aabf-a168-e053-2a95a90a41722020-12-27WarningsExact identifier
spl id: b77c5598-1da6-198b-e053-2a95a90a3385
spl set id: a92d6720-aabf-a168-e053-2a95a90a4172

Reported adverse events (FAERS/openFDA)#

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