Label: OIL CLEARING MATTE MOISTURIZER- avobenzone, octinoxate, oxybenzone, and octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68479-140-00, 68479-140-01, 68479-140-02 - Packager: Dermalogica, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 6, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 30 minutes before sun exposure.
- Reapply:
- at least every two hours.
- Use a water resistant sunscreen if swimming or sweating.
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Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses.
- Children under 6 months: ask a doctor.
- Other information
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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
- PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton
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INGREDIENTS AND APPEARANCE
OIL CLEARING MATTE MOISTURIZER
avobenzone, octinoxate, oxybenzone, and octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 25 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 60 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-140-02 1 in 1 CARTON 1 59 mL in 1 TUBE 2 NDC:68479-140-01 14 mL in 1 TUBE 3 NDC:68479-140-00 2 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/29/2013 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations Cosway 620899877 MANUFACTURE(68479-140) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-140)
