Principal Display Panel - Statement Of Identity
Britto Facial Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)
Britto Facial Sunscreen Broad Spectrum Spf 50
FDA Label NDC 77069-003
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 Britto Facial Sunscreen Broad Spectrum Spf 50 (NDC 77069-003). 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 - uses, drug facts panel - warnings, otc - do not use, otc - stop use, otc - ask doctor, 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 3.00% ----- 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
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
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.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Ask Doctor
Stop use and ask a doctor if rash occurs.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - 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: - 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
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.
Package Label - Principal Display Panel
50 ml NDC 77069-003-01
100 ml NDC 77069-003-02
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