Principal Display Panel - Statement Of Identity
Lip Balm Sunscreen Broad Spectrum SPF 30
Per Sole By Britto Lip Balm Sunscreen Broad Spectrum Spf 30
FDA Label NDC 77069-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mr2 Usa Corporation for the product Per Sole By Britto Lip Balm Sunscreen Broad Spectrum Spf 30 (NDC 77069-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding principal display panel - statement of identity, drug facts panel - active ingredients, drug facts panel - purpose, drug facts panel - use, drug facts panel - warnings, drug facts panel - warnings - do not use, drug facts panel - warnings - when using this product, drug facts panel - warnings - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts Panel - Active Ingredients
Avobenzone 3.0% ----- Sunscreen
Homosalate 8.2% ----- Sunscreen
Octinoxate 7.5% ------- Sunscreen
Octocrylene 7.0% ----- Sunscreen
Drug Facts Panel - Purpose
Purpose: sunscreen
Drug Facts Panel - Use
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
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
Do not use on damaged or broken skin.
Drug Facts Panel - Warnings - When Using This Product
When using this product keep out of eyes. Rinse with water to remove.
Drug Facts Panel - Warnings - Stop Use
Stop use and ask a doctor if rash occurs.
Drug Facts Panel - Warnings - Keep Out Of Reach Of Children,
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Drug Facts Panel - Directions
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
Protect the product in this container from excessive heat and direct sun.
Drug Facts Panel - Inactive Ingredients
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
Contact weekdays from 9AM to 5PM at 1-305-646-1169.
Package Label - Principal Display Panel
NDC 77069-001-01
Level 1 - cylinder (stick)
NDC 77069-001-01
Level 2 - blister (3 x stick)
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