BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION - octinoxate, octisalate, octocrylene, oxybenzone gel 
Enaltus Inc

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.

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bioCorneum + plus SPF 30 advanced SCAR SUPERVISION

bioCorneum + plus SPF 30 advanced SCAR SUPERVISION


Active ingredients

Octinoxate 7.5%
Octisalate 5.0%
Octocrylene 10%
Oxybenzone 6.0%

Purpose

Sunscreen

Uses

bioCorneumis a unique scar therapy providing a patented silicone gel to help prevent abnormal scar formation with high protection sunscreen agents.

Warnings

For external use only

Keep out of reach of children.


Avoid direct contact with eyes, mucous membranes, third degree burns, and open wounds.

Should not be used on dermatological conditions that disrupt the integrity of the skin.

If irritation occurs, discontinue use and consult your physician.

Directions

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:

Other information

Inactive ingredients

Polysiloxanes, Silicon Dioxide, Isopropyl Myristate

Questions?

1-800-240-8227

Representative Labeling

bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 50g (43474-001-50)
bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 20g (43474-001-20)
bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 10g (43474-001-10)



Outer Label

Inner Label

Insert

Insert 2

BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION 
octinoxate, octisalate, octocrylene, oxybenzone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43474-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43474-001-501 in 1 CARTON
150 g in 1 BOTTLE, PUMP
2NDC:43474-001-201 in 1 CARTON
220 g in 1 BOTTLE, PUMP
3NDC:43474-001-101 in 1 CARTON
310 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/10/2014
Labeler - Enaltus Inc (038868036)
Establishment
NameAddressID/FEIBusiness Operations
Formulated Solutions, LLC143266687manufacture(43474-001)

Revised: 4/2014
Document Id: e22951c5-cacf-47cb-9bb3-f722520a33e7
Set id: f87a0c39-bf55-4547-87b1-2415d72391c9
Version: 1
Effective Time: 20140410
 
Enaltus Inc