PURELIGHT  SPF50- avobenzone and octinoxate lotion 
Dermalogica, 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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PureLight
SPF50

Drug Facts

Active ingredients

Avobenzone (3.0%)

Octinoxate (7.5%)

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 reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, Glycerin, C12-15 Alkyl Benzoate, Polysorbate 80, Dimethyl Capramide, Sodium Hyaluronate Crosspolymer, Cananga Odorata Flower Oil, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil, Lavendula Spica (Lavender) Flower Oil, Laminaria Ochroleuca Extract, Palmaria Palmata Extract, Oligopeptide-34, Dipotassium Glycyrrhizate, Lactobacillus/Pumpkin Fruit Ferment Filtrate, Niacinamide, Zinc Glycinate, Polysorbate 60, Ammonium Acryloyldimethyltaurate/VP Copolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Butylene Glycol Behenate, Glyceryl Polyacrylate, Disodium EDTA, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments?

Call toll free 1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

pure
light

spf
50

broad
spectrum

UVA high protection

PowerBright TRx

1.7 US FL OZ / 50 mL e

dermalogica®

Principal Display Panel - 50 mL Tube Carton
PURELIGHT   SPF50
avobenzone and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Glycerin (UNII: PDC6A3C0OX)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Dimethyl Capramide (UNII: O29Y6X2JEZ)  
Cananga Oil (UNII: 8YOY78GNNX)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Lavandin Oil (UNII: 9RES347CKG)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Laminaria Ochroleuca (UNII: 4R2124HE76)  
Dulse (UNII: 7832HOY4ZQ)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
Niacinamide (UNII: 25X51I8RD4)  
Zinc Glycinate (UNII: 681VJX72FE)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)  
Isohexadecane (UNII: 918X1OUF1E)  
Butylene Glycol Behenate (UNII: X0IW5BP6ZL)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-213-021 in 1 CARTON02/18/2014
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-213-002 mL in 1 POUCH; Type 0: Not a Combination Product02/18/2014
3NDC:68479-213-0110 mL in 1 TUBE; Type 0: Not a Combination Product02/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35202/18/2014
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
THIBIANT083913913MANUFACTURE(68479-213)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-213)

Revised: 12/2017
Document Id: 78139a5a-f5bf-4a31-9e16-e95371b0e9d9
Set id: 880d83ff-3e25-4409-b8bb-7e8d1db2ee6d
Version: 3
Effective Time: 20171211
 
Dermalogica, Inc.