FDA.reportPublic FDA data

NOEVIR RAYSELA

Manufacturer
NOEVIR USA INC
Effective date
2009-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:10

Label at a glance#

ProductNOEVIR RAYSELA
Active ingredientZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Drug Facts
Active Ingredients                       Purpose
ZINC OXIDE  14.25%                  Sunscreen
OCTINOXATE  7.5%                   Sunscreen
TITANIUM DIOXIDE 2.07%         Sunscreen

Uses
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Provides high protection against sunburn.
Warnings
For external use only.
When using this product
  • Keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if
  • Rash or irritation develops and lasts.
Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply evenly before sun exposure.
  • Children under 6 months of age ask a doctor.
  • Reapply as needed or after towel drying, swimming or sweating.
Other Information
Sun Alert
Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tube image
tube image

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62908-011-022019-10-21C16284748780-1956f9ecf-c900-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62908-011-01NOEVIR RAYSELA35 g in 1 TUBECREAM351
62908-011-02NOEVIR RAYSELA1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62908-011NOEVIR RAYSELA (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE) CREAM [NOEVIR USA INC]1Legacy NDC, 2 package rows20100101_f63dd9ef-a65a-4d0a-abb9-981f5fd4979c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62908-01162908-011-01, 62908-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML · Source PDF

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
7eebb3b0-6583-47fe-8679-e894f1740645f63dd9ef-a65a-4d0a-abb9-981f5fd4979c2009-11-12Exact identifier
spl id: 7eebb3b0-6583-47fe-8679-e894f1740645
spl set id: f63dd9ef-a65a-4d0a-abb9-981f5fd4979c

Reported adverse events (FAERS/openFDA)#

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