LASTING RESULTS MOISTURIZER- octocrylene, octinoxate, oxybenzone,octisalate, avobenzone lotion

Lasting Results Moisturizer by

Drug Labeling and Warnings

Lasting Results Moisturizer by is a Otc medication manufactured, distributed, or labeled by Biopelle, Inc., Englewood Lab, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octocrylene   10%

Octinoxate   7.5%

Oxybenzone   5%

Octisalate   5%

Avobenzone   3%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  

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

• apply to face and under throat after cleansing
• reapply:
• • after excessive perspiration
• 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 15 or higher and other sun protection measures including:
• • limit time in the sun, especially from 10 a.m. - 2 p.m.
• • wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months:  Ask a doctor

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

• protect this product from excessive heat and direct sun
  

Questions or comments?

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

Package Label

Principal Display

Peel Label

INGREDIENTS AND APPEARANCE

LASTING RESULTS MOISTURIZER 
octocrylene, octinoxate, oxybenzone,octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42485-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42485-007-01	75 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2012

Labeler - Biopelle, Inc. (808158823)

Registrant - Biopelle, Inc. (808158823)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, LLC		172198223	manufacture