Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10.0% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 2.75% Sunscreen
Oxybenzone 6.0% Sunscreen
Ultra Light Sunscreen Broad Spectrum Spf 50
FDA Label NDC 57627-117
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Merle Norman Cosmetics for the product Ultra Light Sunscreen Broad Spectrum Spf 50 (NDC 57627-117). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
· helps prevent sunburn
· If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun
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.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
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.
Dosage & Administration
Directions
• For sunscreen use:
• apply liberally and evenly 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply 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: Ask a doctor
Inactive Ingredient
Inactive ingredients:
Water, Cyclopentasiloxane, Butyloctyl Salicylate, Pentylene Glycol, Glycerin, Silica, Potassium Cetyl Phosphate, Dimethicone, Hydrogenated Palm Glycerides, Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate, Polyisobutene, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Methyl Methacrylate Crosspolymer, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/Dimethicone Copolymer, Trimethylsiloxysilicate, Caprylyl/Capryl Glucoside, Xanthan Gum, Disodium EDTA, BHT, Methylisothiazolinone, Caprylyl Glycol, Fragrance
Package Label.Principal Display Panel
Carton (Carton)
Tube (Tube)
ULTRA LIGHT SUNSCREEN
BROAD SPECTRUM SPF 50
Merle Norman
Established in Los Angeles since 1931
113 g NET WT. 4 OZ.
* Please review the disclaimer below.
