FDA.reportPublic FDA data

Sunscreen

Manufacturer
NATURAL AND ORGANIC FORMULATIONS (PTY) LTD
Effective date
2023-10-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:17:25

Label at a glance#

ProductSunscreen
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

30mL Sunscreen Label Drug Facts Active Ingredient Section30mL Sunscreen Label Drug Facts Active Ingredient Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

30mL Sunscreen Label Drug Facts Children Section30mL Sunscreen Label Drug Facts Children Section

OTC - PURPOSE SECTION

30mL Sunscreen Label Drug Facts Purpose Section30mL Sunscreen Label Drug Facts Purpose Section

DOSAGE & ADMINISTRATION SECTION

30mL Sunscreen Label Drug Facts Directions Section30mL Sunscreen Label Drug Facts Directions Section30mL Sunscreen Label Drug Facts Directions Continued Section30mL Sunscreen Label Drug Facts Directions Continued Section

WARNINGS SECTION

30mL Sunscreen Label Drug Facts Warnings Section30mL Sunscreen Label Drug Facts Warnings Section

INACTIVE INGREDIENT SECTION

30mL Sunscreen Label Drug Facts Inactive Ingredient Section30mL Sunscreen Label Drug Facts Inactive Ingredient Section

INDICATIONS & USAGE SECTION

30mL Sunscreen Label Drug Facts Uses Section30mL Sunscreen Label Drug Facts Uses Section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30mL Sunscreen 30mL Sunscreen Label PDP30mL Sunscreen Label PDPlabel Principal Display Panel

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83748-00183748-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHOREA ROBUSTA RESINXUK1106UBOIACT
DEHYDROACETIC ACID2KAG279R6RIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
ZINC SULFATE89DS0H96TBIACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
SUNFLOWER OIL3W1JG795YIIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
ASCORBYL PALMITATEQN83US2B0NIACT
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX6RG2461FCHIACT
MYROTHAMNUS FLABELLIFOLIA LEAF6Y9E0R40J5IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ISOSTEARIC ACIDX33R8U0062IACT
TOXICODENDRON SUCCEDANEUM FRUIT WAX684PA7HRMIIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
JOJOBA OIL724GKU717MIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
ALOE VERA LEAFZY81Z83H0XIACT
FERRIC OXIDE RED1K09F3G675IACT
TOCOPHEROLR0ZB2556P8IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
GLYCERYL OLEATE4PC054V79PIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ZINC OXIDESOI2LOH54ZACTIB
ISOAMYL LAURATEM1SLX00M3MIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
SHEA BUTTERK49155WL9YIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BENZYL ALCOHOLLKG8494WBHIACT
WATER059QF0KO0RIACT

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
1be24959-0ace-e4c6-e063-6294a90a437807654845-3108-8811-e063-6294a90a80f02024-06-27WarningsExact identifier
spl set id: 07654845-3108-8811-e063-6294a90a80f0

Reported adverse events (FAERS/openFDA)#

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