FDA.reportPublic FDA data

Wax SPF 50

Manufacturer
Biomin LLC.
Effective date
2022-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:02

Label at a glance#

ProductWax SPF 50
Active ingredientZINC OXIDE, ALLANTOIN
Label structure7 sections

Indications and uses

Temporarily protects and helps relieve chapped or chafed skin. Helps prevent and protect from the drying effects of wind and cold weather. Helps prevent sunburn. Higher SPF gives more sunburn protection.

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Use a water resistant sunscreen if swimming or sweating. Reapply at least every two hours. Children under 6 months of age: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun p...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.00%

Allantoin 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve chapped or chafed skin. Helps prevent and protect from the drying effects of wind and cold weather. Helps prevent sunburn. Higher SPF gives more sunburn protection.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.
  • Do not use deep or puncture wounds animal bites serious burns.

Stop use and ask a doctor 

OTC - STOP USE SECTION

  • If rash occurs conditions worsens symptoms last more than 7 days or clear up again within a few days.

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes.
  • Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed. Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every two hours.
  • Children under 6 months of age: Ask a doctor.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Simmondsia Chinensis (Jojoba) Seed Oil, Jojoba Esters, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Argania Spinosa Kernel Oil (Argan Oil), Tocopherol, Bisabolol, Calcium Silicate, Phytosteryl/Behenyl/Octyldodecyl Lauroyl Glutamate, Oryza Sativa (Rice) Bran Oil, Oryza Sativa (Rice) Bran Wax, Rhus Succedanea Fruit Wax, Helianthus Annuus (Sunflower) Seed Oil

Other Information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82177-002-002024-01-30C16284748780-11030e365-5b41-111a-e063-dadaa90a10e2Wax + SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82177-002-00Wax SPF 5060 mL in 1 JAROINTMENT601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82177-002WAX SPF 50 (ZINC OXIDE, ALLANTOIN) OINTMENT [BIOMIN LLC.]1Legacy NDC, 1 package rows20220702_e078798d-24da-9adf-e053-2995a90a76de.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82177-00282177-002-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL724GKU717MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ARGAN OIL4V59G5UW9XIACT
TOCOPHEROLR0ZB2556P8IACT
LEVOMENOL24WE03BX2TIACT
CALCIUM SILICATES4255P4G5MIACT
RICE BRAN OILLZO6K1506AIACT
RICE BRANR60QEP13ICIACT
SUNFLOWER OIL3W1JG795YIIACT
ZINC OXIDESOI2LOH54ZACTIM
ALLANTOIN344S277G0ZACTIB

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
e0787c0a-b4a9-5302-e053-2995a90a0c85e078798d-24da-9adf-e053-2995a90a76de2022-06-02WarningsExact identifier
spl id: e0787c0a-b4a9-5302-e053-2995a90a0c85
spl set id: e078798d-24da-9adf-e053-2995a90a76de

Reported adverse events (FAERS/openFDA)#

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