FDA.reportPublic FDA data

SKINPERFECT PRIMER SPF30

Manufacturer
Dermalogica, LLC. | McKenna
Effective date
2024-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:30

Label at a glance#

ProductSKINPERFECT PRIMER SPF30
Active ingredientZinc Oxide
Label structure10 sections

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, espec...

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 (25.0%).

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

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.
  • Childen 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

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Isododecane, Butyloctyl Salicylate, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Titanium Dioxide, Polysilicone-11, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Argania Spinosa Kernel Oil, PEG/PPG-18/18 Dimethicone, Palmitoyl Tripeptide-1, Dipotassium Glycyrrhizate, Hyaluronic Acid, Lavandula Hybrida Oil, Eucalyptol, Lavandula Angustifolia (Lavender) Flower Extract, Tocopheryl Acetate, Sodium PCA, Tocopherol, Bisabolol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Isononyl Isononanoate, Carnosine, Caprylyl Glycol, Silica Silylate, Pentylene Glycol, Laureth-12, Ethylhexylglycerin, Mica, Glycerin, Isopropyl Titanium Triisostearate, Water/Aqua/Eau, Ozokerite, Propanediol, Tin Oxide, Linalool, Limonene, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499).

Questions / comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

skinperfect
primer

SPF
30

high
protection

UVA
UVB
broad spectrum

smoothing +
illuminating
tinted primer

Daily Skin Health

0.75 US FL OZ / 22 mL ℮

dermalogica

PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-132-00SKINPERFECT PRIMER SPF302 mL in 1 POUCHLOTION21
68479-132-01SKINPERFECT PRIMER SPF307 mL in 1 TUBELOTION71
68479-132-01SKINPERFECT PRIMER SPF301 in 1 CARTONLOTION11
68479-132-02SKINPERFECT PRIMER SPF301 in 1 CARTONLOTION11
68479-132-02SKINPERFECT PRIMER SPF3022 mL in 1 TUBELOTION221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-132SKINPERFECT PRIMER SPF30 (ZINC OXIDE) LOTION [DERMALOGICA, LLC.]1Current NDC, 5 package rows20240427_692f9cda-eb6c-431f-a575-3778c6e12e3b.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-13268479-132-02, 68479-132-01, 68479-132-00

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
Zinc OxideSOI2LOH54ZACTIB
Dimethicone92RU3N3Y1OIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
IsododecaneA8289P68Y2IACT
Butyloctyl Salicylate2EH13UN8D3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone25G622K2RAIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
Titanium Dioxide15FIX9V2JPIACT
ARGAN OIL4V59G5UW9XIACT
PEG/PPG-18/18 Dimethicone9H0AO7T794IACT
Water059QF0KO0RIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
MicaV8A1AW0880IACT
Isononyl IsononanoateS4V5BS6GCXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAVANDIN OIL9RES347CKGIACT
LEVOMENOL24WE03BX2TIACT
CERESINQ1LS2UJO3AIACT
Pentylene Glycol50C1307PZGIACT
Propanediol5965N8W85TIACT
Carnosine8HO6PVN24WIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
Caprylyl Glycol00YIU5438UIACT
GlycerinPDC6A3C0OXIACT
Isopropyl Titanium Triisostearate949E3KBJ1IIACT
Ethylhexylglycerin147D247K3PIACT
SODIUM PIDOLATE1V74VH163TIACT
Laureth-12OAH19558U1IACT
Hyaluronic AcidS270N0TRQYIACT
EucalyptolRV6J6604TKIACT
STANNIC OXIDEKM7N50LOS6IACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
TocopherolR0ZB2556P8IACT
Palmitoyl Tripeptide-1RV743D216MIACT

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
SKINPERFECT PRIMER SPF30ZINC OXIDEDermalogica, LLC.692f9cda-eb6c-431f-a575-3778c6e12e3b2024-04-23WarningsExact identifier
ndc (package): 68479-132-00
ndc (package): 68479-132-01
ndc (package): 68479-132-02
ndc (product): 68479-132
ndc11 (package): 68479013200
ndc11 (package): 68479013202
ndc11 (package): 68479013201
spl id: c34e4089-afe7-441d-b62d-8bdb33dfdd1b
spl set id: 692f9cda-eb6c-431f-a575-3778c6e12e3b

Reported adverse events (FAERS/openFDA)#

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