FDA.reportPublic FDA data

Clearing Defense SPF 30

Manufacturer
Dermalogica, Inc. | Cosway
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:49:37

Label at a glance#

ProductClearing Defense SPF 30
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure10 sections

Indications and 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.

Dosage and administration

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. 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 ...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • On damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician

OTC - STOP USE SECTION

  • if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.
  • 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

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

extra matte
sun protection

2.0 US FL OZ / 59 mL ℮

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68479-807-002022-02-08C16284748780-1d6a99b3a-0018-a426-e053-dadaa90af4c2Clearing Defense SPF 30
68479-807-012022-02-08C16284748780-1d6a99b3a-0018-a426-e053-dadaa90af4c2Clearing Defense SPF 30
68479-807-022022-02-08C16284748780-1d6a99b3a-0018-a426-e053-dadaa90af4c2Clearing Defense SPF 30
68479-807-032022-02-08C16284748780-1d6a99b3a-0018-a426-e053-dadaa90af4c2Clearing Defense SPF 30
68479-807-002022-01-28C16284748780-1d6a99b3a-0018-a426-e053-dadaa90af4c2Clearing Defense SPF 30
68479-807-012022-01-28C16284748780-1d6a99b3a-0018-a426-e053-dadaa90af4c2Clearing Defense SPF 30
68479-807-022022-01-28C16284748780-1d6a99b3a-0018-a426-e053-dadaa90af4c2Clearing Defense SPF 30
68479-807-032022-01-28C16284748780-1d6a99b3a-0018-a426-e053-dadaa90af4c2Clearing Defense SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-807-00Clearing Defense SPF 302 mL in 1 POUCHLOTION24
68479-807-01Clearing Defense SPF 3015 mL in 1 TUBELOTION154
68479-807-02Clearing Defense SPF 301 in 1 CARTONLOTION14
68479-807-02Clearing Defense SPF 3059 mL in 1 TUBELOTION594
68479-807-03Clearing Defense SPF 307 mL in 1 TUBELOTION74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-807CLEARING DEFENSE SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [DERMALOGICA, INC.]4Current NDC, Legacy NDC, 5 package rows20250101_2388ae53-0a61-43c0-8936-c639887a5649.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-80768479-807-03, 68479-807-02, 68479-807-01, 68479-807-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
Silicon DioxideETJ7Z6XBU4IACT
Butyloctyl Salicylate2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
GlycerinPDC6A3C0OXIACT
Polyglyceryl-2 Stearate253MC0P0YVIACT
Saccharide IsomerateW8K377W98IIACT
STARCH, TAPIOCA24SC3U704IIACT
CORIANDER OIL7626GC95E5IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
Sodium Ascorbyl Phosphate836SJG51DRIACT
SALIX ALBA BARK205MXS71H7IACT
TerpineolR53Q4ZWC99IACT
Thymol3J50XA376EIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
Potassium Sorbate1VPU26JZZ4IACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Arachidyl Alcohol1QR1QRA9BUIACT
Glyceryl Stearate SEFCZ5MH785IIACT
PEG-100 StearateYD01N1999RIACT
DOCOSANOL9G1OE216XYIACT
LEVOMENOL24WE03BX2TIACT
Xanthan GumTTV12P4NEEIACT
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMEREPA1872R1NIACT
Arachidyl Glucoside6JVW35JOOJIACT
Ethylhexylglycerin147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
Trisodium Ethylenediamine DisuccinateYA22H34H9QIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
Sodium Hydroxide55X04QC32IIACT
Pentylene Glycol50C1307PZGIACT
Propanediol5965N8W85TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clearing Defense SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDermalogica, Inc.2388ae53-0a61-43c0-8936-c639887a56492024-12-26WarningsExact identifier
ndc (package): 68479-807-00
ndc (package): 68479-807-03
ndc (package): 68479-807-01
ndc (package): 68479-807-02
ndc (product): 68479-807
ndc11 (package): 68479080701
ndc11 (package): 68479080703
ndc11 (package): 68479080700
ndc11 (package): 68479080702
spl id: 1c40d9aa-8e05-4c31-aec4-882f0662f458
spl set id: 2388ae53-0a61-43c0-8936-c639887a5649

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.