Per Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 30

Manufacturer
MR2 USA Corporation | PHARMATURA-INDUSTRIA DE COSMETICOS 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#

ProductPer Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 30
Active ingredientOCTINOXATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure10 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: ask a doctor. 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 measu...

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

Lip Balm Sunscreen Broad Spectrum SPF 30

Drug Facts Panel - Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0% ----- Sunscreen

Homosalate 8.2% ----- Sunscreen

Octinoxate 7.5% ------- Sunscreen

Octocrylene 7.0% ----- Sunscreen

Drug Facts Panel - Purpose

OTC - PURPOSE SECTION

Purpose: sunscreen

Drug Facts Panel - Use

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.

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

Stop use and ask a doctor if rash occurs.

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

Drug Facts Panel - Warnings - Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

Drug Facts Panel - Warnings - When using this product

OTC - WHEN USING SECTION

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

Drug Facts Panel - Warnings - Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

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

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 at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

Children under 6 months of age: ask a doctor.

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.

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

Beeswax, Butylated Hydroxytoluene, C12-15 Alkyl Benzoate, Carnauba Wax, Fragrance, Hydrogenated Vegetable Glycerides, Isopropyl Palmitate, Mineral Oil, Ozokerite, Paraffin, Synthetic Candellila Wax, Theobroma Cacao (Cocoa) Seed Butter.

Questions or comments

OTC - QUESTIONS SECTION

Contact weekdays from 9AM to 5PM at 1-305-646-1169.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 77069-001-01

Level 1 - cylinder (stick) Label Label 1Label Label 1

NDC 77069-001-01

Level 2 - blister (3 x stick)

Label Level 2.1Label Level 2.1Label Level 2.2Label Level 2.2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77069-001-012022-01-28C16284748780-1d6a99b39-8188-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77069-001-01Per Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 303.5 g in 1 CYLINDERLIPSTICK3.52
77069-001-01Per Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 303 in 1 BLISTER PACKLIPSTICK32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77069-001PER SOLE BY BRITTO LIP BALM SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE) LIPSTICK [MR2 USA CORPORATION]2Legacy NDC, 2 package rows20201228_a9f25fca-0f4f-c46b-e053-2995a90afa91.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77069-00177069-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
b77c5d6c-aa65-32f1-e053-2995a90abd7ca9f25fca-0f4f-c46b-e053-2995a90afa912020-12-27WarningsExact identifier
spl id: b77c5d6c-aa65-32f1-e053-2995a90abd7c
spl set id: a9f25fca-0f4f-c46b-e053-2995a90afa91

Reported adverse events (FAERS/openFDA)#

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