FDA.reportPublic FDA data

ZINC FIVE-O

Manufacturer
ASTIVITA LIMITED
Effective date
2022-01-27
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 23:47:44

Label at a glance#

ProductZINC FIVE-O SPF-50
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours Sun Protection Measures: • Spending time in the sun increases your 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 measures includi...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 25%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun

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 doctor if rash occurs.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 minutes before sun exposure.

Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours Sun Protection Measures: • Spending time in the sun increases your 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 measures including:
•Limit time in the sun, especially from 10 a.m. – 2 p.m.
•Wear long-sleeved shirts, pants, hats, and sunglasses
•Children under 6 months of age: ask a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at temperatures below 90°F.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Zinc Five-0_Sunscreen_SPF-50_Page_101b LBL_Zinc Five-0_Sunscreen_SPF-50_Page_101b LBL_Zinc Five-0_Sunscreen_SPF-50_Page_201b LBL_Zinc Five-0_Sunscreen_SPF-50_Page_2

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
80982-003-392022-07-29C16284748780-1e4f33bdf-b0a5-d8a0-e053-dadaa90a6e4eZINC FIVE-O SPF-50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80982-003-39ZINC FIVE-OSPF-50240 g in 1 TUBELOTION24013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80982-003ZINC FIVE-O SPF-50 (ZINC OXIDE) LOTION [ASTIVITA LIMITED]13Legacy NDC, 1 package rows20220129_b318e85f-cec9-85d5-e053-2a95a90a6e3c.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80982-00380982-003-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GLYCERINPDC6A3C0OXIACT
COCONUT ALKANES1E5KJY107TIACT
JOJOBA OIL724GKU717MIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
YELLOW WAX2ZA36H0S2VIACT
ISOSTEARIC ACIDX33R8U0062IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MALTODEXTRIN7CVR7L4A2DIACT
PHENYLPROPANOL0F897O3O4MIACT
PROPANEDIOL5965N8W85TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CETYL PHOSPHATEVT07D6X67OIACT
SODIUM CHLORIDE451W47IQ8XIACT
EDETATE DISODIUM7FLD91C86KIACT
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
d69e4b0d-d8be-911b-e053-2995a90aa50eb318e85f-cec9-85d5-e053-2a95a90a6e3c2022-01-27WarningsExact identifier
spl id: d69e4b0d-d8be-911b-e053-2995a90aa50e
spl set id: b318e85f-cec9-85d5-e053-2a95a90a6e3c

Reported adverse events (FAERS/openFDA)#

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