FDA.reportPublic FDA data

MINERAL SUNSCREEN

Manufacturer
RECOVERY CARE PRODUCTS, LLC
Effective date
2022-01-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:24

Label at a glance#

ProductMINERAL SUNSCREEN BROAD SPECTRUM SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

HELPS PREVENT SUNBURN

Dosage and administration

PLEASE ADHERE TO YOUR PHYSICIAN'S PROTOCOL FOR THIS PRODUCT* WOULD MUST BE FULLY CLOSED AND NO LONGER SCABBED GENTLY GLIDE OVER SCAR 15 MINUTES PRIOR TO SUN EXPOSURE REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING, IMMEDIATELY AFTER TOWEL DRYING, EVERY TWO HOURS CHILDREN UNDER 6 MONTHS: CONSULT YOUR PHYSICIAN FOR OPTIMAL RESULTS, USE IN CONJUNCTION WITH RCP SCAR MANAGEMENT* *FOR MORE INFORMATION ON PROTOCOLS VIS...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 20%

PURPOSE:

OTC - PURPOSE SECTION

SUNSCREEN

USES:

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN

WARNINGS:

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY.
  • DO NOT USE ON DAMAGED OR BROKEN 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 IMMEDIATELY.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • PLEASE ADHERE TO YOUR PHYSICIAN'S PROTOCOL FOR THIS PRODUCT*
  • WOULD MUST BE FULLY CLOSED AND NO LONGER SCABBED
  • GENTLY GLIDE OVER SCAR 15 MINUTES PRIOR TO SUN EXPOSURE
  • REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING, IMMEDIATELY AFTER TOWEL DRYING, EVERY TWO HOURS
  • CHILDREN UNDER 6 MONTHS: CONSULT YOUR PHYSICIAN
  • FOR OPTIMAL RESULTS, USE IN CONJUNCTION WITH RCP SCAR MANAGEMENT*

*FOR MORE INFORMATION ON PROTOCOLS VISIT WWW.RCPCARE.COM/RECOVERYRESOURCES

OTHER INFORMATION:

OTHER SAFETY INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF JUICE (ALOE VERA)*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CERA ALBA (BEESWAX)*, COCOS NUCIFERA (COCONUT) OIL*, COPERNICIA CERIFERA (CARNAUBA) WAX*, EUPHORBIA CERIFERA CERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, RICINUS COMMUNIS (CASTOR) SEED OIL*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL

*CERTIFIED ORGANIC INGREDIENTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Mineral Sunscreen_front01b UC_Mineral Sunscreen_front

01b UC_Mineral Sunscreen_back01b UC_Mineral Sunscreen_back

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
72525-003-012023-07-28C16284748780-10191ceaa-6bd8-198a-e063-dbdaa90aec3eRECOVERY CARE PRODUCTS - MINERAL SUNSCREEN SPF 30 (72525-003)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72525-003-01MINERAL SUNSCREENBROAD SPECTRUM SPF 3014 g in 1 TUBESTICK143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72525-003MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) STICK [RECOVERY CARE PRODUCTS, LLC]3Legacy NDC, 1 package rows20220123_9156d2cc-5f76-4c65-9aed-71d155d8246e.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
72525-00372525-003-01

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
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
CANDELILLA WAXWL0328HX19IACT
SUNFLOWER OIL3W1JG795YIIACT
CASTOR OILD5340Y2I9GIACT
COCOA BUTTER512OYT1CRRIACT
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
d61d3545-f900-85c1-e053-2995a90aff619156d2cc-5f76-4c65-9aed-71d155d8246e2022-01-21WarningsExact identifier
spl id: d61d3545-f900-85c1-e053-2995a90aff61
spl set id: 9156d2cc-5f76-4c65-9aed-71d155d8246e

Reported adverse events (FAERS/openFDA)#

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