Oil Clearing Matte Moisturizer (Avobenzone, Octinoxate, Oxybenzone, And Octisalate) Lotion [Dermalogica, Inc.] -

OIL CLEARING MATTE MOISTURIZER (AVOBENZONE, OCTINOXATE, OXYBENZONE, AND OCTISALATE) LOTION [DERMALOGICA, INC.]
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NDC	68479-140-00, 68479-140-01, 68479-140-02
Set ID	2a02bd94-a7ab-4b71-b05f-5a45a92c179c
Category	HUMAN OTC DRUG LABEL
Packager	Dermalogica, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

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

Sunscreen
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
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
- Apply liberally 30 minutes before sun exposure.
- Reapply:
  - at least every two hours.
  - Use a water resistant sunscreen if swimming or sweating.
- 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
- Protect this product from excessive heat and direct sun.
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

INGREDIENTS AND APPEARANCE

OIL CLEARING MATTE MOISTURIZER
avobenzone, octinoxate, oxybenzone, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68479-140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/29/2013

Labeler - Dermalogica, Inc. (177698560)

Name	Address	ID/FEI	Business Operations
Establishment
Cosway		620899877	MANUFACTURE(68479-140)

Name	Address	ID/FEI	Business Operations
Establishment
Diamond Wipes		161104729	MANUFACTURE(68479-140)

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