FDA.reportPublic FDA data

CLEARING DEFENSE SPF30

Manufacturer
Dermalogica, LLC. | Cosway | McKenna
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:40:06

Label at a glance#

ProductCLEARING DEFENSE SPF30
Active ingredientOctocrylene, Homosalate, Octisalate, Avobenzone
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 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 ...

Storage and handling

Protect this product from excessive heat and direct sun. Store below 77°F/25°C. Contains sorbates and benzoates.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (w/w)

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (3.0%)
Homosalate (7.0%)
Octisalate (5.0%)
Octocrylene (8.0%)

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

SPL UNCLASSIFIED 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 Doctor

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 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

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.
  • Store below 77°F/25°C.
  • Contains sorbates and benzoates.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

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

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-872-00CLEARING DEFENSE SPF302 mL in 1 TUBELOTION21
68479-872-02CLEARING DEFENSE SPF301 in 1 CARTONLOTION11
68479-872-02CLEARING DEFENSE SPF3059 mL in 1 TUBELOTION591
68479-872-05CLEARING DEFENSE SPF3010 mL in 1 TUBELOTION101
68479-872-05CLEARING DEFENSE SPF301 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-872CLEARING DEFENSE SPF30 (OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE) LOTION [DERMALOGICA, LLC.]1Current NDC, 5 package rows20241204_2cb559d3-dd79-4951-ad38-190fd4dd7c40.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-87268479-872-02, 68479-872-05, 68479-872-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octocrylene5A68WGF6WMACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
Butyloctyl Salicylate2EH13UN8D3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 StearateYD01N1999RIACT
Saccharide IsomerateW8K377W98IIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Pentylene Glycol50C1307PZGIACT
Arachidyl Alcohol1QR1QRA9BUIACT
Propanediol5965N8W85TIACT
STARCH, TAPIOCA24SC3U704IIACT
Caprylyl Glycol00YIU5438UIACT
DOCOSANOL9G1OE216XYIACT
LEVOMENOL24WE03BX2TIACT
Xanthan GumTTV12P4NEEIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
Arachidyl Glucoside6JVW35JOOJIACT
Ethylhexylglycerin147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
Sodium Ascorbyl Phosphate836SJG51DRIACT
CORIANDER OIL7626GC95E5IACT
Trisodium Ethylenediamine DisuccinateYA22H34H9QIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SALIX ALBA BARK205MXS71H7IACT
TerpineolR53Q4ZWC99IACT
Thymol3J50XA376EIACT
Sodium Hydroxide55X04QC32IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
Potassium Sorbate1VPU26JZZ4IACT
Sodium BenzoateOJ245FE5EUIACT

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 SPF30OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.2cb559d3-dd79-4951-ad38-190fd4dd7c402024-11-27WarningsExact identifier
ndc (package): 68479-872-02
ndc (package): 68479-872-00
ndc (package): 68479-872-05
ndc (product): 68479-872
ndc11 (package): 68479087205
ndc11 (package): 68479087200
ndc11 (package): 68479087202
spl id: 2e3e3e8e-5faf-4b4a-989c-bdc171b89bfa
spl set id: 2cb559d3-dd79-4951-ad38-190fd4dd7c40

Reported adverse events (FAERS/openFDA)#

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