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 253 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a8812b-70ff-e8aa-e063-6294a90a09f82024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.3a548deb-3670-4c5b-a139-796701801fed2024-12-19WarningsExact identifier
application number: M020
CLE CCC Olive Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.be4434c0-cbdd-46cb-8015-4c7859e80d4a2024-12-19WarningsExact identifier
application number: M020
CLE CCC Golden MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.de50e956-a014-4147-922b-63c95fa6f86b2024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.44cbb226-83ed-401b-baf8-ca8e4740dbef2024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.615f5e39-695d-41d4-af59-e0d3b76789bb2024-12-19WarningsExact identifier
application number: M020
CLE CCC Warm DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.6ab3e360-8104-4439-93fb-e11bc4a775582024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.a297ff64-678c-4936-8384-022606a2f33c2024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a22024-12-19WarningsExact identifier
application number: M020
CLE CCC Cool Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.2e0365f9-d3c6-4404-90ac-772a829b3ade2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEGOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abae8f-53db-b592-e063-6294a90adabb2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29aba80c-55b7-b8d9-e063-6294a90a5cc12024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abe97b-e9b3-6e27-e063-6294a90ae3ed2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDENOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abdf3c-fb54-a5e3-e063-6394a90af4502024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM FAIRZINC OXIDECOSMAX USA, CORPORATION29ac756b-3df7-50c9-e063-6394a90aa4792024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM RICHZINC OXIDECOSMAX USA, CORPORATION29ac51a0-07e7-ad7b-e063-6294a90ae7772024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEPESTZINC OXIDECOSMAX USA, CORPORATION29ad12e2-0a2e-7138-e063-6394a90aebaf2024-12-19WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products, Inc.f2e34230-7bfb-455f-8b33-6bff96fd9f0a2024-12-19WarningsExact identifier
application number: M020
Anew Platinum DayCream Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONECOSMAX USA, CORPORATION56200212-bedc-6e1e-e063-6394a90a36662024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELLOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29868d60-b900-e0ad-e063-6294a90af87a2024-12-18WarningsExact 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