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

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.

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Clearing Defense SPF 30

Drug Facts

Active ingredients

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

Purpose

Sunscreen

Uses

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

Other information

Inactive ingredients

Water/Aqua/Eau, Butylene Glycol, Silica, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, VP/Eicosene Copolymer, Polyglyceryl-2 Distearate, 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, Tocopheryl Acetate, Potassium Cetyl Phosphate, Arachidyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Behenyl Alcohol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arachidyl Glucoside, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Citric Acid, Sodium Citrate, Sodium Hydroxide, Glycerin, Bisabolol, Pentylene Glycol, Propanediol, Caprylyl Glycol, 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

extra matte
sun protection

2.0 US FL OZ / 59 mL ℮

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton
CLEARING DEFENSE SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-807
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate80 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
Glycerin (UNII: PDC6A3C0OX)  
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, COLD PRESSED (UNII: AKN3KSD11B)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Glyceryl Stearate SE (UNII: FCZ5MH785I)  
PEG-100 Stearate (UNII: YD01N1999R)  
DOCOSANOL (UNII: 9G1OE216XY)  
LEVOMENOL (UNII: 24WE03BX2T)  
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)  
Pentylene Glycol (UNII: 50C1307PZG)  
Propanediol (UNII: 5965N8W85T)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-807-037 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2020
2NDC:68479-807-021 in 1 CARTON12/01/2020
259 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:68479-807-0115 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2020
4NDC:68479-807-002 mL in 1 POUCH; Type 0: Not a Combination Product12/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/01/2020
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway052400223MANUFACTURE(68479-807)

Revised: 1/2022
Document Id: 5352caa8-77b3-4f40-b974-c5781d4c3f87
Set id: 2388ae53-0a61-43c0-8936-c639887a5649
Version: 3
Effective Time: 20220131
 
Dermalogica, Inc.