Label: CLEARING DEFENSE SPF 30- avobenzone, homosalate, octisalate, and octocrylene lotion
- NDC Code(s): 68479-807-00, 68479-807-01, 68479-807-02, 68479-807-03
- Packager: Dermalogica, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 31, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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Directions
- Apply generously to cleansed face and neck, preferably 30 minutes prior to sun exposure.
- Reapply:
- at least every two hours.
- Use a water resistant sunscreen if swimming or sweating.
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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
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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
- PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CLEARING DEFENSE SPF 30
avobenzone, homosalate, octisalate, and octocrylene lotionProduct 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) 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 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 12/01/2020 2 NDC:68479-807-02 1 in 1 CARTON 12/01/2020 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 12/01/2020 4 NDC:68479-807-00 2 mL in 1 POUCH; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/01/2020 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations Cosway 052400223 MANUFACTURE(68479-807)
