OIL CLEARING MATTE MOISTURIZER- avobenzone, octinoxate, oxybenzone, and octisalate 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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Oil Clearing Matte Moisturizer

Drug Facts

Active ingredients

Avobenzone (2.5%), Octinoxate (6.0%), Octisalate (5.0%), Oxybenzone (4.0%).

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 physician

  • 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, Butylene Glycol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Silica, Dimethyl Capramide, Citrus Aurantium Dulcis (Orange) Peel Oil, Cariandrum Sativum (Coriander) Fruit Oil, Citrus Aurantifolia (Lime) Peel Oil, Citrus Aurantium Amara (Bitter Orange) Peel Oil, Citrus Aurantium Dulcis (Orange) Flower Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Medica Limonum (Lemon) Peel Oil, Elettaria Cardamomum Seed Oil, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Lavandula Hybrida Oil, Salvia Sclarea (Clary) Oil, Zingiber Officinale (Ginger) Root Oil, Enantia Chlorantha Bark Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Betula Alba Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Salix Alba (Willow) Bark Extract, Oleanolic Acid, Tocopherol, Cetearyl Phosphate, Stearic Acid, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Nylon-12, Xanthan Gum, Cetyl Alcohol, Aminomethyl Propanol, Sodium Benzoate, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin, Titanium Dioxide (CI 77891).

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

dermalogica®
clear

spf
15
broad
spectrum

Oil Clearing

Matte
Moisturizer

2.0 US FL OZ / 59 mL e

Principal Display Panel - 59 mL Tube Carton
OIL CLEARING MATTE MOISTURIZER 
avobenzone, octinoxate, oxybenzone, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone25 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Dimethyl Capramide (UNII: O29Y6X2JEZ)  
Orange Oil (UNII: AKN3KSD11B)  
Coriander Oil (UNII: 7626GC95E5)  
Citrus Aurantiifolia Seed Oil (UNII: EW089HAI77)  
Bitter Orange Oil (UNII: 9TLV70SV6I)  
Citrus Sinensis Flower Oil (UNII: AJ56JP5TFP)  
Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
Lemon Oil (UNII: I9GRO824LL)  
Cardamom Oil (UNII: JM0KJ091HZ)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Clove Leaf Oil (UNII: VCA5491KVF)  
Lavandin Oil (UNII: 9RES347CKG)  
Clary Sage Oil (UNII: 87L0D4U3M0)  
Ginger Oil (UNII: SAS9Z1SVUK)  
Annickia Chlorantha Bark (UNII: H70115MP4A)  
Arctium Lappa Root (UNII: 597E9BI3Z3)  
Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
Betula Pubescens Bark (UNII: 3R504894L9)  
Glycyrrhiza Glabra (UNII: 2788Z9758H)  
Salix Alba Bark (UNII: 205MXS71H7)  
Oleanolic Acid (UNII: 6SMK8R7TGJ)  
Tocopherol (UNII: R0ZB2556P8)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
Nylon-12 (UNII: 446U8J075B)  
Xanthan Gum (UNII: TTV12P4NEE)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Aminomethylpropanol (UNII: LU49E6626Q)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-140-021 in 1 CARTON
159 mL in 1 TUBE
2NDC:68479-140-0114 mL in 1 TUBE
3NDC:68479-140-002 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/29/2013
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway620899877MANUFACTURE(68479-140)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-140)

Revised: 2/2014
Document Id: 539d880a-3bfd-4912-af64-4efe8b8bd3ec
Set id: 2a02bd94-a7ab-4b71-b05f-5a45a92c179c
Version: 1
Effective Time: 20140206
 
Dermalogica, Inc.