FDA.reportPublic FDA data

Invisible Physical Defense SPF 30

Manufacturer
Dermalogica, Inc. | McKenna
Effective date
2020-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:56

Label at a glance#

ProductInvisible Physical Defense SPF 30
Active ingredientZinc Oxide
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 liberally 30 minutes before 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, especia...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (20%)

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 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 liberally 30 minutes before 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, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dimethicone, Butyloctyl Salicylate, Butylene Glycol, Glycerin, Silica, Polyhydroxystearic Acid, PEG-10 Dimethicone, Argania Spinosa Kernel Oil, Cordyceps Sinensis Extract, Trametes Versicolor Extract, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Lavandula Spica (Lavender) Flower Oil, Tocopheryl Acetate, Sodium Chloride, Stearalkonium Hectorite, Pentylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Propanediol, Dimethicone Crosspolymer, Sodium Citrate, Propylene Carbonate, Xanthan Gum, Caprylyl Glycol, Bisabolol, Lavandula Hybrida Oil, Ethylhexylglycerin, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate.

Questions or comments

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

invisible
physical
defense

dermalogica

SPF
30

broad spectrum

weightless
physical
sunscreen

1.7 US FL OZ / 50 mL ℮

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68479-909-002022-01-28C16284748780-1d6a99b39-6d92-a426-e053-dadaa90af4c2Invisible Physical Defense SPF 30
68479-909-012022-01-28C16284748780-1d6a99b39-6d92-a426-e053-dadaa90af4c2Invisible Physical Defense SPF 30
68479-909-022022-01-28C16284748780-1d6a99b39-6d92-a426-e053-dadaa90af4c2Invisible Physical Defense SPF 30
68479-909-042022-01-28C16284748780-1d6a99b39-6d92-a426-e053-dadaa90af4c2Invisible Physical Defense SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-909-00Invisible Physical Defense SPF 30177 mL in 1 TUBELOTION1771
68479-909-01Invisible Physical Defense SPF 301 in 1 CARTONLOTION11
68479-909-01Invisible Physical Defense SPF 307 mL in 1 TUBELOTION71
68479-909-02Invisible Physical Defense SPF 3050 mL in 1 TUBELOTION501
68479-909-04Invisible Physical Defense SPF 30177 mL in 1 TUBELOTION1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-909INVISIBLE PHYSICAL DEFENSE SPF 30 (ZINC OXIDE) LOTION [DERMALOGICA, INC.]1Legacy NDC, 5 package rows20200313_78355b1d-dd91-42c4-931d-36b8a5b9a546.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-90968479-909-01, 68479-909-02, 68479-909-04, 68479-909-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
Dimethicone92RU3N3Y1OIACT
Butyloctyl Salicylate2EH13UN8D3IACT
GlycerinPDC6A3C0OXIACT
Butylene Glycol3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ARGAN OIL4V59G5UW9XIACT
OPHIOCORDYCEPS SINENSIS8Q1GYP08KUIACT
TRAMETES VERSICOLOR FRUITING BODY4C900477MTIACT
HYALURONATE SODIUMYSE9PPT4THIACT
EUCALYPTUS OIL2R04ONI662IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAVENDER OILZBP1YXW0H8IACT
Sodium Chloride451W47IQ8XIACT
Stearalkonium HectoriteOLX698AH5PIACT
Pentylene Glycol50C1307PZGIACT
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone25G622K2RAIACT
Propanediol5965N8W85TIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
Propylene Carbonate8D08K3S51EIACT
Xanthan GumTTV12P4NEEIACT
Caprylyl Glycol00YIU5438UIACT
LEVOMENOL24WE03BX2TIACT
Ethylhexylglycerin147D247K3PIACT
LAVANDIN OIL9RES347CKGIACT
Sodium Hydroxide55X04QC32IIACT
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
bbee87e7-daab-4699-a9ff-f9d22fa5ffe578355b1d-dd91-42c4-931d-36b8a5b9a5462020-03-05WarningsExact identifier
spl id: bbee87e7-daab-4699-a9ff-f9d22fa5ffe5
spl set id: 78355b1d-dd91-42c4-931d-36b8a5b9a546

Reported adverse events (FAERS/openFDA)#

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