Medication Guide App

SPF 15 Protective Balm with UVA/UVB Sunscreens

Dosage form: stick
Ingredients: OCTINOXATE 7.5g in 100g, OCTISALATE 3g in 100g, OXYBENZONE 3g in 100g
Labeler: Laboratoire Dr Renaud inc.
NDC Code: 62499-420

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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 •

Helps protect from sunburn.Formulated to minimize allergic risks.

Apply liberally and evenly 15 to 30 minutes before exposure to the sun.Reapply every 2 hours and after swimming perspiring heavily.

image of cartridge label
image of carton label



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.

SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS 
octinoxate octisalate oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-420
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE3 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED 
LANOLIN 
OCTYLDODECANOL 
PETROLATUM 
ISOPROPYL PALMITATE 
CERESIN 
CANDELILLA WAX 
YELLOW WAX 
CARNAUBA WAX 
ACETATE ION 
LEVOMENOL 
PANTHENOL 
ISOPROPYLPARABEN 
ISOBUTYLPARABEN 
BUTYLPARABEN 
ALPHA-TOCOPHEROL 
CORN OIL 
SUNFLOWER OIL 
T-BUTYLHYDROQUINONE 
GLYCERYL MONOOLEATE 
BETA CAROTENE 
PROPYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
Product Characteristics
Colorred (dark red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62499-420-111 CARTRIDGE (CARTRIDGE) in 1 BOX
1NDC:62499-420-023.8 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/21/2011
Labeler - Laboratoire Dr Renaud inc. (202501565)
Registrant - Laboratoire Dr Renaud inc (202501565)
Establishment
NameAddressID/FEIOperations
Laboratoire Dr Renaud inc202501565manufacture

Revised: 03/2011
 
Laboratoire Dr Renaud inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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