FDA.reportPublic FDA data

NON-NANO SUNSCREEN

Manufacturer
ProCaps Laboratories, Inc. | Thibiant International, Inc.
Effective date
2019-02-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:00

Label at a glance#

ProductNON-NANO SUNSCREEN SPF 40
Active ingredientZINC OXIDE
Label structure8 sections

Dosage and administration

For sunscreen use apply liberally and evenly 15minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: Ask a doctor. Sun Protection Measures: Spending time in the sun increasesyour risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 17.5%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USE

INDICATIONS & USAGE 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.
  • Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • For sunscreen use
  • apply liberally and evenly 15minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor.
  • Sun Protection Measures: Spending time in the sun increasesyour risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measuresincluding
  • limit time in the sun, especially from 10 a.m.–2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun
  • may stain some fabrics

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Silica, Coco-Glucoside, Microcrystalline Cellulose, Glycerin, Pyrus Malus (Apple) Fruit Extract, Cocoyl Proline, Humulus Lupulus (Hops) Extract, Isostearic Acid, Phenylpropanol, Polyhydroxystearic Acid, Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

606114-01U Sole_Box_6oz_MOCKUPwDIELINE606114-01U Sole_Box_6oz_MOCKUPwDIELINE

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
72879-505-022022-07-29C16284748780-1e4f33bdf-a4d7-d8a0-e053-dadaa90a6e4eSolé non-nano zinc oxide SPF 40 sunscreen
72879-505-042022-07-29C16284748780-1e4f33bdf-a4d7-d8a0-e053-dadaa90a6e4eSolé non-nano zinc oxide SPF 40 sunscreen
72879-505-062022-07-29C16284748780-1e4f33bdf-a4d7-d8a0-e053-dadaa90a6e4eSolé non-nano zinc oxide SPF 40 sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72879-505-02NON-NANO SUNSCREENSPF 401 in 1 BOXLOTION12
72879-505-02NON-NANO SUNSCREENSPF 4059 mL in 1 TUBELOTION592
72879-505-04NON-NANO SUNSCREENSPF 401 in 1 BOXLOTION12
72879-505-04NON-NANO SUNSCREENSPF 40118 mL in 1 TUBELOTION1182
72879-505-06NON-NANO SUNSCREENSPF 401 in 1 BOXLOTION12
72879-505-06NON-NANO SUNSCREENSPF 40177 mL in 1 TUBELOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72879-505NON-NANO SUNSCREEN SPF 40 (ZINC OXIDE) LOTION [PROCAPS LABORATORIES, INC.]2Legacy NDC, 6 package rows20190329_6f55b142-e726-400a-ab4f-59630b49208f.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72879-50572879-505-02, 72879-505-04, 72879-505-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
JOJOBA OIL724GKU717MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
COCO-GLYCERIDESISE9I7DNUGIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
GLYCERINPDC6A3C0OXIACT
APPLEB423VGH5S9IACT
COCOYL PROLINE0IH06971TFIACT
HOPS01G73H6H83IACT
ISOSTEARIC ACIDX33R8U0062IACT
PHENYLPROPANOL0F897O3O4MIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
XANTHAN GUMTTV12P4NEEIACT

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
3de0ebf2-5cda-43a1-8972-0ec16379b75c6f55b142-e726-400a-ab4f-59630b49208f2019-02-27Exact identifier
spl id: 3de0ebf2-5cda-43a1-8972-0ec16379b75c
spl set id: 6f55b142-e726-400a-ab4f-59630b49208f

Reported adverse events (FAERS/openFDA)#

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