FDA Label for Spf 15 Protective Balm With Uva/uvb Sunscreens
View Indications, Usage & Precautions
Spf 15 Protective Balm With Uva/uvb Sunscreens Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoire Dr Renaud Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Octinoxate (Octyl Methoxycinnamate) à 7.5 % w/w, Octisalate (Octyl Salicylate) à 3% w/w, Oxybenzone à 3% w/w.
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.