FDA.reportPublic FDA data

SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30

Manufacturer
SOLVADERM LLC
Effective date
2024-03-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:05

Label at a glance#

ProductSOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30
Active ingredientOCTOCRYLENE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *If pregnant or breast-feeding, ask a health care professional before use. *For children under 6 months of age: Ask a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 10.0% 
Zinc Oxide 7.0%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

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 if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply to all skin exposed to the sun.

*Apply liberally and evenly 15 minutes before sun exposure.

*Reapply at least every 2 hours.

*Use a water-resistant sunscreen if swimming or sweating.

*If pregnant or breast-feeding, ask a health care professional before use.

*For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Starch Octenyl succinate, Aqua (Deionized Water), Beeswax, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Chamomilla Matricaria Extract, Cetearyl Alcohol, Cyclopentasiloxane, Diisopropyl Adipate, Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Parfum (Fragrance)., PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Sorbitan Stearate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84197-467-00SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-3050 g in 1 JARCREAM501
84197-467-00SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-301 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84197-467SOLVADERM DERMAXSOL DERMAL DEFENSE MOISTURIZER SPF-30 (OCTOCRYLENE, ZINC OXIDE) CREAM [SOLVADERM LLC]1Current NDC, 2 package rows20240322_0f9a507a-1b72-45f8-a8a8-b7a92a85607f.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84197-46784197-467-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
WATER059QF0KO0RIACT
YELLOW WAX2ZA36H0S2VIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYALURONIC ACIDS270N0TRQYIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30OCTOCRYLENE, ZINC OXIDESOLVADERM LLC0f9a507a-1b72-45f8-a8a8-b7a92a85607f2024-03-21WarningsExact identifier
ndc (package): 84197-467-00
ndc (product): 84197-467
ndc11 (package): 84197046700
spl id: 1427e6f9-923d-4285-e063-6294a90a99e5
spl set id: 0f9a507a-1b72-45f8-a8a8-b7a92a85607f

Reported adverse events (FAERS/openFDA)#

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