FDA.reportPublic FDA data

PLANT AND MINERAL SUNSCREEN

Manufacturer
SKINourishment, LLC.
Effective date
2021-09-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:21

Label at a glance#

ProductPLANT AND MINERAL SUNSCREEN SPF 50
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure  Children under 6 months of age: Ask a doctor At least every 2 hours

Storage and handling

Protect this product in this container from excessive heat and direct sun. Sore at temperatures below 90F.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

20.2% ZINC OXIDE (non-nano)

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Skin Cancer/Skin Aging Alert:

WARNINGS SECTION

Spending time sun may increase your risk of skin cancer and ealry skin aging. For external use only. Do not use on broken or damaged skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor 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 15 minutes before sun exposure
  •  Children under 6 months of age: Ask a doctor
  • At least every 2 hours

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Protect this product in this container from excessive heat and direct sun. Sore at temperatures below 90F.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride (MCT) Oil, Shorea Stenoptera (Illipe) Butter, Organic Ricinus Communis L. (Castor) Seed Oil, Butyrospermum Parkii (Shea) Butter, Oryza Sativa (Rice) Bran Wax, Organic Rubus Idaeus (Raspberry) Seed Oil, Persea Gratissima (Avocado) Oil, Citrullus Vulgaris (Watermelon) Seed, Organic Mentha Piperita (Peppermint) Oil, Non-GMO Tocopherol (Vitamin E)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SKIN NOURISHMENT PLANT AND MINERAL SUNSCREEN SPF 50 LOTION.jpgSKIN NOURISHMENT PLANT AND MINERAL SUNSCREEN SPF 50 LOTION.jpg

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
82233-101-112022-07-29C16284748780-1e4f33bdf-b0f0-d8a0-e053-dadaa90a6e4eSKINourishment - PLANT AND MINERAL SUNSCREEN SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82233-101-11PLANT AND MINERAL SUNSCREENSPF 5088 mL in 1 BOTTLELOTION882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82233-101PLANT AND MINERAL SUNSCREEN SPF 50 (ZINC OXIDE) LOTION [SKINOURISHMENT, LLC.]2Legacy NDC, 1 package rows20210915_8b59f588-65a2-43bb-9ead-3f9d800e3f1d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82233-10182233-101-11

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
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHOREA STENOPTERA SEED BUTTER129R0X862GIACT
CASTOR OILD5340Y2I9GIACT
RICE BRANR60QEP13ICIACT
ORYZA SATIVA WHOLE84IVV0906ZIACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
AVOCADO OIL6VNO72PFC1IACT
WATERMELON SEED OILL33J06UQTTIACT
MENTHA PIPERITA79M2M2UDA9IACT
TOCOPHEROLR0ZB2556P8IACT
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
cbe6d19c-a6c1-e9cf-e053-2a95a90a8d0d8b59f588-65a2-43bb-9ead-3f9d800e3f1d2021-09-13WarningsExact identifier
spl id: cbe6d19c-a6c1-e9cf-e053-2a95a90a8d0d
spl set id: 8b59f588-65a2-43bb-9ead-3f9d800e3f1d

Reported adverse events (FAERS/openFDA)#

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