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

Key Label Information#

Active Ingredients And Purpose

Drug Facts Panel - Active Ingredients

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

Purpose: sunscreen

Uses

Drug Facts Panel - 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

Warnings

Drug Facts Panel - Warnings

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.

Directions And Dosage

Drug Facts Panel - Directions

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.

Other Label Information

Principal Display Panel - Statement of identity

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

Drug Facts Panel - Other information

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

Drug Facts Panel - Inactive Ingredients

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

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

Label Images#

LABEL_Britto Facial Sunscreen SPF50_50 ml
LABEL_Britto Facial Sunscreen SPF50_50 ml
LABEL_Britto Facial Sunscreen SPF50_100 ml
LABEL_Britto Facial Sunscreen SPF50_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#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

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.

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 77069-003-01 100 ml NDC 77069-003-02

Source Document#

Source XML