FDA.reportPublic FDA data

Sunplus SPF50 Face Body Sunscreen

Product NDC
65112-304
11-digit product format
651120304
Labeler code
65112
Product ID
65112-304_4a08871f-25e4-215d-e063-6394a90ab8a8
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
I.Shay Cosmetics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-06-01
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE
Active strength
.06; .05; .02; .15 g/118mL; g/118mL; g/118mL; g/118mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sunplus SPF50 Face Body Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE.06 g/118mL
OCTISALATE.05 g/118mL
AVOBENZONE.02 g/118mL
HOMOSALATE.15 g/118mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
26d55baf-66dc-b1b8-e063-6394a90a670dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65112-304-012026-01-29C16284748780-149896155-b02f-586f-e063-e6dba90add90Sunplus SFP50 Face Body Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65112-304-01Sunplus SPF50 Face Body Sunscreen118 mL in 1 TUBELOTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65112-304SUNPLUS SPF50 FACE BODY SUNSCREEN (SUNSCREEN) LOTION [I.SHAY COSMETICS]1Current NDC, 1 package rows20241115_26d55baf-66dc-b1b8-e063-6394a90a670d.zip

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 92 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f4599b-de62-2bc7-e063-6394a90a69ab2025-12-31WarningsExact identifier
application number: M020
Hawaiian Tropic Everyday Active SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc8e2ee8-e67f-ef5d-e053-2995a90a15202025-12-31WarningsExact identifier
application number: M020
Sunscreen Glowing, SPF 30SUNSCREEN GLOWING LOTIONCardinal Health, Inc28ed3b60-1139-f657-e063-6394a90a52fa2025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYCardinal Health, inc.293e9656-8644-b9aa-e063-6294a90a5b272025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYFSA Store Inc473d6804-8d20-6899-e063-6294a90a31312025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47428cd4-fbad-ba7a-e063-6394a90a1c5c2025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47433a62-91e0-b031-e063-6294a90a0d492025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4743b6a9-4d79-1b2b-e063-6394a90a97102025-12-31WarningsExact identifier
application number: M020
Royal Jelly Radiance Foundation Broad Spectrum SPF 20 EarthOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.0edc7bd4-9350-48e1-bbfe-e6450458ae592025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - BronzeOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.90fbf555-106c-4131-b572-ead9bbb246e62025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - HoneyOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.1accbe67-c722-4af7-8422-0559ac4a987a2025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - BareOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5c0805c7-9b92-4c08-877c-64e7203084302025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20- NaturalOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.0cc5429d-ace4-4060-b993-1b607218eaf82025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20-NudeOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.b1851c5d-32ad-482a-bd24-2f280a68ef9e2025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 -SpiceOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6164dc23-81c2-48b8-b309-2c5a81fe13a42025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4744e501-f12a-6d25-e063-6394a90a25742025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - TawnyOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb62025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - CappuccinoOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.30601a73-089e-4fa7-8fb7-6b108498934a2025-12-31WarningsExact identifier
application number: M020
Good Karma Dry Oil Mineral Sunscreen SPF-30ZINC OXIDE SUNSCREENSOLARA SUNCARE, INC.209c4913-29e6-24ca-e063-6294a90a68722025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47456bf5-9f6c-e6a5-e063-6294a90a70542025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65112-304-0165112030401118 mL in 1 TUBE (65112-304-01) 118 ml2004-06-01NoNoCurrent