FDA.reportPublic FDA data

INVISIBLE PHYSICAL DEFENSE SPF30

Manufacturer
Dermalogica, Inc. | McKenna
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:50

Label at a glance#

ProductINVISIBLE PHYSICAL DEFENSE SPF30
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 (20.9%)

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, Butyloctyl Salicylate, Dimethicone, Butylene Glycol, Glycerin, Caprylyl Methicone, Silica, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Octyldodecanol, Sodium Chloride, Cordyceps Sinensis Extract, Poria Cocos Sclerotium Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Lavandula Hybrida Oil, Tocopheryl Acetate, PEG-10 Dimethicone, Pentylene Glycol, Caprylyl Glycol, Ethylhexylglycerin, Bisabolol, Sodium Hyaluronate, Xylose, Dimethicone Crosspolymer, Sorbitan Olivate, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Eucalyptol, Xanthan Gum, Tocopherol, Sodium Citrate, Sodium Hydroxide, Propanediol, Stearalkonium Hectorite, Propylene Carbonate, Potassium Sorbate, Sodium Benzoate, Linalool, Limonene.

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

dermalogica

invisible
physical
defense

SPF
30
FPS

broad spectrum

weightless
physical
sunscreen

Aust L 355173

1.7 US FL OZ / 50 mL e

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 50 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
68479-991-00INVISIBLE PHYSICAL DEFENSE SPF302 mL in 1 POUCHLOTION23
68479-991-02INVISIBLE PHYSICAL DEFENSE SPF301 in 1 CARTONLOTION13
68479-991-02INVISIBLE PHYSICAL DEFENSE SPF3050 mL in 1 TUBELOTION503
68479-991-04INVISIBLE PHYSICAL DEFENSE SPF30177 mL in 1 TUBELOTION1773
68479-991-05INVISIBLE PHYSICAL DEFENSE SPF307 mL in 1 TUBELOTION73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-991INVISIBLE PHYSICAL DEFENSE SPF30 (ZINC OXIDE) LOTION [DERMALOGICA, INC.]3Current NDC, Legacy NDC, 5 package rows20250101_2e5e6861-25ea-4605-8e59-41d852c002b7.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
68479-99168479-991-02, 68479-991-04, 68479-991-05, 68479-991-00

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Dimethicone92RU3N3Y1OIACT
Butylene Glycol3XUS85K0RAIACT
GlycerinPDC6A3C0OXIACT
Caprylyl TrisiloxaneQ95M2P1KJLIACT
Silicon DioxideETJ7Z6XBU4IACT
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone25G622K2RAIACT
Argan Oil4V59G5UW9XIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
Octyldodecanol461N1O614YIACT
Sodium Chloride451W47IQ8XIACT
Sorbitan OlivateMDL271E3GRIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
Pentylene Glycol50C1307PZGIACT
Propanediol5965N8W85TIACT
Octyldodecyl Xyloside8Z6VNR46QMIACT
Peg-30 Dipolyhydroxystearate (4000 Mw)9713Q0S7FOIACT
Stearalkonium HectoriteOLX698AH5PIACT
Caprylyl Glycol00YIU5438UIACT
Xanthan GumTTV12P4NEEIACT
Ophiocordyceps Sinensis8Q1GYP08KUIACT
FU LINGXH37TWY5O4IACT
Sodium Citrate, Unspecified Form1Q73Q2JULRIACT
Ethylhexylglycerin147D247K3PIACT
Propylene Carbonate8D08K3S51EIACT
Lavandin Oil9RES347CKGIACT
Levomenol24WE03BX2TIACT
Hyaluronate SodiumYSE9PPT4THIACT
Green Tea LeafW2ZU1RY8B0IACT
Potassium Sorbate1VPU26JZZ4IACT
EucalyptolRV6J6604TKIACT
Sodium BenzoateOJ245FE5EUIACT
Sodium Hydroxide55X04QC32IIACT
XyloseA1TA934AKOIACT
Lavandula Angustifolia Subsp. Angustifolia Flower19AH1RAF4MIACT

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
INVISIBLE PHYSICAL DEFENSE SPF30ZINC OXIDEDermalogica, Inc.2e5e6861-25ea-4605-8e59-41d852c002b72024-12-27WarningsExact identifier
ndc (package): 68479-991-02
ndc (package): 68479-991-04
ndc (package): 68479-991-05
ndc (package): 68479-991-00
ndc (product): 68479-991
ndc11 (package): 68479099105
ndc11 (package): 68479099104
ndc11 (package): 68479099102
ndc11 (package): 68479099100
spl id: e2eac8c9-1085-4256-b917-c04f1dafdc4c
spl set id: 2e5e6861-25ea-4605-8e59-41d852c002b7

Reported adverse events (FAERS/openFDA)#

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