BRITTO BODY SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream 
MR2 USA Corporation

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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Principal Display Panel - Statement of Identity

PDP - Britto Body Sunscreen SPF50_100ml_REV01.jpg

Drug Facts Panel - Active Ingredients

Labelling - Britto Body Sunscreen SPF50_100ml_REV01_

Drug Facts Panel - Purpose

Labelling - Britto Body Sunscreen SPF50_100ml_REV01

Drug Facts Panel - Uses

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Drug Facts Panel - Warnings

Labelling - Britto Body Sunscreen SPF50_100ml

Drug Facts Panel - Warnings - Do not use

Warnings - Do Not Use

Drug Facts Panel - Warnings - Stop use

Warnings - Stop Use

Drug Facts Panel - Warnings - Ask a doctor

Warnings - Stop Use and Ask a Doctor

Drug Facts Panel - Warnings - When using this product

Warnings - When using

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

Warnings - Keep out of reach of children

Drug Facts Panel - Directions

Directions

Durg Facts Panel - Other Information

Other Information

Drug Facts Panel - Inactive Ingredients

Inactive Ingredients

Questions and reporting of adverse events

Questions or comments

Principal Display Panel

PDP - Britto Body Sunscreen SPF50_100ml_REV01

BRITTO BODY SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77069-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL PALMITATE (UNII: 6Y2XJ05B35) 1.32 g  in 100 mL
WATER (UNII: 059QF0KO0R) 37.05 g  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 2.24 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2 g  in 100 mL
GLYCERYL DIPALMITATE (UNII: 7775E5IR3L) 1.32 g  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE) 0.2 g  in 100 mL
POLYESTER-7 (UNII: 0841698D2F) 0.6 g  in 100 mL
STEARIC ACID (UNII: 4ELV7Z65AP) 0.6 g  in 100 mL
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.2 g  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.5 g  in 100 mL
METHYLPARABEN (UNII: A2I8C7HI9T) 0.2 g  in 100 mL
GLYCERYL DISTEARATE (UNII: 73071MW2KM) 1.84 g  in 100 mL
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) 3 g  in 100 mL
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) 1 g  in 100 mL
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 0.4 g  in 100 mL
POTASSIUM STEARATE (UNII: 17V812XK50) 0.36 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.32 g  in 100 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.1 g  in 100 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1 g  in 100 mL
EDETATE SODIUM (UNII: MP1J8420LU) 0.05 g  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77069-002-01100 mL in 1 TUBE; Type 0: Not a Combination Product07/15/2020
2NDC:77069-002-02200 mL in 1 TUBE; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/15/2020
Labeler - MR2 USA Corporation (080950597)
Establishment
NameAddressID/FEIBusiness Operations
COSMODERMA INDUSTRIA E COMERCIO LTDA899462110manufacture(77069-002) , pack(77069-002) , label(77069-002)

Revised: 12/2020
Document Id: b77c5598-1da6-198b-e053-2a95a90a3385
Set id: a92d6720-aabf-a168-e053-2a95a90a4172
Version: 2
Effective Time: 20201227
 
MR2 USA Corporation