CLEARING DEFENSE SPF30- octocrylene, homosalate, octisalate, and avobenzone lotion

CLEARING DEFENSE SPF30 by

Drug Labeling and Warnings

CLEARING DEFENSE SPF30 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, LLC., Cosway, McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (w/w)

Avobenzone (3.0%)
Homosalate (7.0%)
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 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 generously to cleansed face and neck, preferably 15 minutes prior to 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.
• Store below 77°F/25°C.
• Contains sorbates and benzoates.

Inactive Ingredients

Water/Aqua/Eau, Butylene Glycol, Butyloctyl Salicylate, Silica, C12-15 Alkyl Benzoate, VP/Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Saccharide Isomerate, Dipotassium Glycyrrhizate, Sodium Ascorbyl Phosphate, Citrus Aurantium Dulcis (Orange) Peel Oil, Camellia Sinensis Leaf Extract, Tapioca Starch, Coriandrum Sativum (Coriander) Fruit Oil, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentylene Glycol, Bisabolol, Arachidyl Glucoside, Arachidyl Alcohol, Xanthan Gum, Behenyl Alcohol, Ethylhexylglycerin, Potassium Cetyl Phosphate, Trisodium Ethylenediamine Disuccinate, Sodium Hydroxide, Citric Acid, Propanediol, Terpineol, Thymol, Sodium Citrate, Potassium Sorbate, Sodium Benzoate, Linalool, Limonene, Geraniol, Citronellol.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

matte finish
won't clog pores

clearing
defense
SPF 30

broad spectrum

dermalogica
clear start

UVA
UVB

high protection

AUST L 465886

2.0 US FL OZ / 59 mL e

INGREDIENTS AND APPEARANCE

CLEARING DEFENSE SPF30 
octocrylene, homosalate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-872
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	8 mg  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	7 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 mg  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Saccharide Isomerate (UNII: W8K377W98I)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Pentylene Glycol (UNII: 50C1307PZG)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Propanediol (UNII: 5965N8W85T)
STARCH, TAPIOCA (UNII: 24SC3U704I)
Caprylyl Glycol (UNII: 00YIU5438U)
DOCOSANOL (UNII: 9G1OE216XY)
LEVOMENOL (UNII: 24WE03BX2T)
Xanthan Gum (UNII: TTV12P4NEE)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Ethylhexylglycerin (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)
CORIANDER OIL (UNII: 7626GC95E5)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SALIX ALBA BARK (UNII: 205MXS71H7)
Terpineol (UNII: R53Q4ZWC99)
Thymol (UNII: 3J50XA376E)
Sodium Hydroxide (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-872-02	1 in 1 CARTON	12/01/2024
1		59 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-872-05	1 in 1 CARTON	12/01/2024
2		10 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68479-872-00	2 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	12/01/2024

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		052400223	MANUFACTURE(68479-872)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-872)