Label: BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION- octinoxate, octisalate, octocrylene, oxybenzone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 43474-001-10, 43474-001-20, 43474-001-50 - Packager: Enaltus Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated April 10, 2014
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- Official Label (Printer Friendly)
- bioCorneum + plus SPF 30 advanced SCAR SUPERVISION
- Active ingredients
- Uses
- Warnings
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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
- Inactive ingredients
- Questions?
- Representative Labeling
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INGREDIENTS AND APPEARANCE
BIOCORNEUM PLUS SPF 30 ADVANCED SCAR SUPERVISION
octinoxate, octisalate, octocrylene, oxybenzone gelProduct 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)
