Otc - Active Ingredient
Octinoxate (Octyl Methoxycinnamate) à 7.5 % w/w, Octisalate (Octyl Salicylate) à 3% w/w, Oxybenzone à 3% w/w.
Spf 15 Protective Balm With Uva/uvb Sunscreens
FDA Label NDC 62499-420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoire Dr Renaud Inc. for the product Spf 15 Protective Balm With Uva/uvb Sunscreens (NDC 62499-420). 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, inactive ingredients, otc - purpose, dosage & administration, package label.principal display panel, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
RICINUS COMMUNIS (CASTOR) SEED OIL • LANOLIN OIL • OCTYLDODECANOL • RED PETROLATUM • ISOPROPYL PALMITATE • OZOKERITE • EUPHORBIA CERIFERA (CANDELILLA) WAX / CIRE DE CANDELILLA • BEESWAX / CIRE D’ABEILLE • COPERNICA CERIFERA (CARNAUBA) WAX / CIRE DE CARNAUBA • TOCOPHERYL ACETATE • BISABOLOL • PANTHENOL • TOCOPHEROL • ZEA MAYS (CORN) OIL • VEGETABLE OIL / HUILE VEGETALE • GLYCERYL OLEATE • BETA-CAROTENE • PROPYLENE GLYCOL • TBHQ • CITRIC ACID • ISOPROPYLPARABEN • ISOBUTYLPARABEN • BUTYLPARABEN •
Otc - Purpose
Helps protect from sunburn.Formulated to minimize allergic risks.
Dosage & Administration
Apply liberally and evenly 15 to 30 minutes before exposure to the sun.Reapply every 2 hours and after swimming perspiring heavily.
Package Label.Principal Display Panel
Image of cartridge labelimage of carton label
Warnings
For external use only.Keep out of children. Avoid direct contact with the eyes. Stop use if signs of rash or irritation appear.Children under 6 months, ask doctor.
* Please review the disclaimer below.
