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

bioCorneum plus SPF 30 advanced SCAR SUPERVISION by

Drug Labeling and Warnings

bioCorneum plus SPF 30 advanced SCAR SUPERVISION by is a Otc medication manufactured, distributed, or labeled by Enaltus Inc, Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• ensure that the affected area is clean and dry
• apply evenly in a thin layer twice daily, 15 minutes before sun exposure
• allow to dry
• children under 6 months: ask a doctor
  

Other information

• store below 25oC (77oF)
  

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43474-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43474-001-50	1 in 1 CARTON
1		50 g in 1 BOTTLE, PUMP
2	NDC: 43474-001-20	1 in 1 CARTON
2		20 g in 1 BOTTLE, PUMP
3	NDC: 43474-001-10	1 in 1 CARTON
3		10 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/10/2014

Labeler - Enaltus Inc (038868036)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	manufacture(43474-001)