FDA.reportPublic FDA data

Noevir Raysela UV Shield Primer

Manufacturer
Nippon Shikizai, Inc.
Effective date
2025-05-14
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:00:58

Label at a glance#

ProductNoevir Raysela UV Shield Primer
Active ingredientZINC OXIDE, OCTINOXATE
Label structure9 sections

Indications and uses

helps prevent sunburn. if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water-resistant sunscreen if swimming or sweating. 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 of 15 or higher and other sun protection measures including: limit time in the ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Protects skins from the sun's harmful rays (UV-A, UV-B) to prevent sunburn, spots and premature signs of aging while keeping your skin hydrated.

  • Broad Spectrum SPF50+ effectively shields UV rays while hydrating skin.
  • Can be used as a makeup base throughout the year.
  • Light-diffusing emulsion creates soft and smoother appearance.
  • Deeply moisturizing without heaviness for youthful looking skin.
  • Specially formulated emulsion provided light, pleasant finish while absorbing excess sebum.

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 6.99%

ZINC OXIDE 17.67%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn.
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure.
  • reapply at least every 2 hours.
  • use a water-resistant sunscreen if swimming or sweating.
  • 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 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-sleeve-shirts pants, hats and sunglasses.
  • children under 6 months: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

  • protect this product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, DISTEARDIMONIUM HECTORITE, HYDROGEN DIMETHICONE, PENTYLENE GLYCOL, GLYCERIN, MAGNESIUM SULFATE, POLYHYDROXYSTEARIC ACID, SORBITAN SESQUIISOSTEARATE, TRIMETHYLSILOXYSILICATE, SILICA DIMETHYL SILYLATE, SODIUM CITRATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TOCOPHEROL, SQUALANE, ALCOHOL, CELLULOSE ACETATE, ASCOPHYLLUM NODOSUM EXTRACT, SORBITOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, PHELLODENDRON AMURENSE BARK EXRACT, BELAMCANDA CHINENSIS ROOT EXTRACT, VITIS VINIFERA (GRAPE) LEAF EXTRACT, CITRUS GRANDIS (GRAPEFRUIT) FRUIT EXTRACT, SPIRAEA ULMARIA FLOWER EXTRACT, PHENOXYETHANOL, FRAGRANCE

Principal Display Panel - Raysela UV Shield Primer Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAYSELA

UV Shield Primer

Base Protection UV

BROAD
SPECTRUM

SPF
50+

NOEVIR

NET WT. 1.7 OZ. - 50g

Principal Display Panel - Raysela UV Shield Primer Label
Principal Display Panel - Raysela UV Shield Primer Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24509-0001-1Noevir Raysela UV Shield Primer50 g in 1 TUBECREAM509
24509-0001-1Noevir Raysela UV Shield Primer1 in 1 BOXCREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24509-0001NOEVIR RAYSELA UV SHIELD PRIMER (ZINC OXIDE, OCTINOXATE) CREAM [NIPPON SHIKIZAI, INC.]9Current NDC, Legacy NDC, 2 package rows20250515_45030b2f-21cf-4285-af12-87ea8f0b8df7.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24509-000124509-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SQUALANEGW89575KF9IACT
TOCOPHEROLR0ZB2556P8IACT
CELLULOSE ACETATE3J2P07GVB6IACT
ROSEMARYIJ67X351P9IACT
ALCOHOL3K9958V90MIACT
PHELLODENDRON AMURENSE BARKPBG27B754GIACT
PUMMELOET1TN5W71XIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
IRIS DOMESTICA ROOTT2MU9QFA87IACT
VITIS VINIFERA LEAFR1H893D80EIACT
ASCOPHYLLUM NODOSUM168S4EO8YJIACT
SORBITOL506T60A25RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ZINC OXIDESOI2LOH54ZACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
Noevir Raysela UV Shield PrimerZINC OXIDE, OCTINOXATENippon Shikizai, Inc.45030b2f-21cf-4285-af12-87ea8f0b8df72025-05-14WarningsExact identifier
ndc (package): 24509-0001-1
ndc (product): 24509-0001
ndc11 (package): 24509000101
spl id: 35131187-5a48-e7e6-e063-6394a90a1352
spl set id: 45030b2f-21cf-4285-af12-87ea8f0b8df7

Reported adverse events (FAERS/openFDA)#

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