CLEARING DEFENSE SPF 30- avobenzone, homosalate, octisalate, and octocrylene lotion

Clearing Defense SPF 30 by

Drug Labeling and Warnings

Clearing Defense SPF 30 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Cosway. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (3.0%), Homosalate (8.0%), Octisalate (5.0%), Octocrylene (8.0%).

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, Silica, Caprylyl Methicone, C12-15 Alkyl Benzoate, VP/Eicosene Copolymer, Dimethyl Capramide, Polyglyceryl-2 Stearate, Saccharide Isomerate, Tapioca Starch, Coriandrum Sativum (Coriander) Fruit Oil, Camellia Sinensis Leaf Extract, Sodium Ascorbyl Phosphate, Salix Alba (Willow) Bark Extract, Terpineol, Thymol, Citrus Aurantium Dulcis (Orange) Peel Oil, Dipotassium Glycyrrhizate, Tocopherol, Potassium Cetyl Phosphate, Arachidyl Alcohol, Glyceryl Stearate SE, PEG-100 Stearate, Behenyl Alcohol, Benzyl Alcohol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arachidyl Glucoside, Ethylhexylglycerin, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Citric Acid, Sodium Citrate, Sodium Hydroxide, Phenoxyethanol.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

dermalogica
clear
start

Mattifying Moisturizer

Clearing Defense
SPF 30

broad spectrum

2.0 US FL OZ / 59 mL e

INGREDIENTS AND APPEARANCE

CLEARING DEFENSE SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-807
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	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
Polyglyceryl-2 Stearate (UNII: 253MC0P0YV)
Saccharide Isomerate (UNII: W8K377W98I)
Starch, Tapioca (UNII: 24SC3U704I)
Coriander Oil (UNII: 7626GC95E5)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)
Salix Alba Bark (UNII: 205MXS71H7)
Terpineol (UNII: R53Q4ZWC99)
Thymol (UNII: 3J50XA376E)
Orange Oil (UNII: AKN3KSD11B)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Tocopherol (UNII: R0ZB2556P8)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
PEG-100 Stearate (UNII: YD01N1999R)
Docosanol (UNII: 9G1OE216XY)
Benzyl Alcohol (UNII: LKG8494WBH)
Xanthan Gum (UNII: TTV12P4NEE)
Ethyl Acrylate/Methacrylic Acid/Steareth-20 Methacrylate Copolymer (UNII: EPA1872R1N)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Ethylhexylglycerin (UNII: 147D247K3P)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Sodium Hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-807-03	7 mL in 1 TUBE; Type 0: Not a Combination Product	05/06/2019
2	NDC: 68479-807-02	1 in 1 CARTON	05/06/2019
2		59 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68479-807-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	05/06/2019
4	NDC: 68479-807-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	05/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/06/2019

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		620899877	MANUFACTURE(68479-807)