LASTING RESULTS MOISTURIZER - octocrylene, octinoxate, oxybenzone,octisalate, avobenzone lotion 
Biopelle, 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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Lasting Results Moisturizer Broad Spectrum SPF 50

Active Ingredients

Octocrylene   10%

Octinoxate   7.5%

Oxybenzone   5%

Octisalate   5%

Avobenzone   3%

Purpose


Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of each of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

water, butyloctyl salicylate, aloe barbadensis leaf juice, propylene glycol, glyceryl stearate, peg-100 stearate, hexyldecanol, stearic acid, allantoin, phenoxyethanol, magnesium ascorbyl phosphate, cetyl alcohol, panthenol, acrylates/C10-30 alkyl acrylate crosspolymer, dimethicone, triethanolamine, caprylyl glycol, chlorphenesin.

Other information

Questions or comments?

Call toll free - 1-866-424-6735 (weekdays)

Package Label

Principal Display

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Peel Label

LastingResultsBottomPly

LASTING RESULTS MOISTURIZER 
octocrylene, octinoxate, oxybenzone,octisalate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42485-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
HEXYLDECANOL (UNII: 151Z7P1317)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PANTHENOL (UNII: WV9CM0O67Z)  
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42485-007-0175 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2012
Labeler - Biopelle, Inc. (808158823)
Registrant - Biopelle, Inc. (808158823)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, LLC172198223manufacture

Revised: 5/2012
Document Id: 51498b64-d362-4176-9944-ca4fc00c2953
Set id: 0bb3c088-f58c-4f5c-8710-599e79066c2e
Version: 1
Effective Time: 20120501
 
Biopelle, Inc.