OIL FREE MATTE SPF 30- avobenzone, homosalate, octisalate, and oxybenzone lotion

Oil Free Matte by

Drug Labeling and Warnings

Oil Free Matte by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Cosway, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 4.0%, Oxybenzone 5.0%.

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 Doctor 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

Inactive ingredients

Water/Aqua/Eau, PPG-3 Benzyl Ether Ethylhexanoate, Butylene Glycol, Nylon-12, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Stearic Acid, Polysorbate 80, Enantia Chlorantha Bark Extract, Camellia Sinensis Leaf Extract, Oleanolic Acid, Niacinamide, Yeast Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Ammonium Glycyrrhizate, Panthenol, Zinc Gluconate, Caffeine, Biotin, Ascorbyl Tetraisopalmitate, Sodium DNA, Tocopherol, Caprylic/Capric Triglyceride, Carbomer, Carthamus Tinctorius (Safflower) Oleosomes, Citrus Grandis (Grapefruit) Peel Oil, Limonene, Tocopherol Acetate, Behenyl Alcohol, Arachidyl Glucoside, Cetyl Alcohol, Glyceryl Stearate SE, Sorbitan Stearate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, Sodium Hydroxide, Disodium EDTA.

Other information

• Protect this product from excessive heat and direct sun

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

oil
free
matte

spf
30

broad
spectrum

mediBac clearing®

1.7 US Fl. Oz.
50 mL e

dermalogica®

INGREDIENTS AND APPEARANCE

OIL FREE MATTE   SPF 30
avobenzone, homosalate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	80 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	40 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PPG-3 Benzyl Ether Ethylhexanoate (UNII: 3N703GY99W)
Butylene Glycol (UNII: 3XUS85K0RA)
Nylon-12 (UNII: 446U8J075B)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)
Stearic Acid (UNII: 4ELV7Z65AP)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Annickia Chlorantha Bark (UNII: H70115MP4A)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Oleanolic Acid (UNII: 6SMK8R7TGJ)
Niacinamide (UNII: 25X51I8RD4)
Yeast, Unspecified (UNII: 3NY3SM6B8U)
Horse Chestnut (UNII: 3C18L6RJAZ)
Ammonium Glycyrrhizate (UNII: 3VRD35U26C)
Panthenol (UNII: WV9CM0O67Z)
Zinc Gluconate (UNII: U6WSN5SQ1Z)
Caffeine (UNII: 3G6A5W338E)
Biotin (UNII: 6SO6U10H04)
Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)
Tocopherol (UNII: R0ZB2556P8)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)
Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
Isohexadecane (UNII: 918X1OUF1E)
Polysorbate 60 (UNII: CAL22UVI4M)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium (UNII: 7FLD91C86K)
Docosanol (UNII: 9G1OE216XY)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-110-02	1 in 1 CARTON
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68479-110-00	2 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/16/2012

Labeler - Dermalogica (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		620899877	MANUFACTURE(68479-110)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-110)