FDA.reportPublic FDA data

RoC Hydration Plus SPF 30

Product NDC
73496-014
11-digit product format
734960014
Labeler code
73496
Product ID
73496-014_45a3e259-aa75-67c1-e063-6294a90a850a
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Roc Skincare
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-27
Substance
OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength
4.5; 5.5; 2; 4 mg/100mL; mg/100mL; mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
RoC Hydration Plus SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4.5 mg/100mL
HOMOSALATE5.5 mg/100mL
AVOBENZONE2 mg/100mL
OCTOCRYLENE4 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45a3e250-8195-344d-e063-6294a90ae681Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73496-014-01RoC Hydration Plus SPF 3050 mL in 1 BOTTLE, PUMPLOTION501
73496-014-02RoC Hydration Plus SPF 3050 mL in 1 TUBELOTION501

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 114 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC36985373-22dd-2232-e063-6394a90a76fb2025-12-16Exact identifier
application number: M020
Matte Defense Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698090a-1639-00f9-e063-6394a90a7dd12025-12-16Exact identifier
application number: M020
Daily Replenish mineral sunscreenZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698d309-b9bf-e197-e063-6294a90af5a12025-12-16Exact identifier
application number: M020
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698f29e-5d80-94af-e063-6394a90a04892025-12-16Exact identifier
application number: M020
Tinted Mineral Primer SPF 40TITANIUM DIOXIDE, ZINC OXIDEJOSEPHINA RAMIREZ365cf2be-8862-3622-e063-6394a90ac4e32025-12-16Exact identifier
application number: M020
SANCTUARY Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECHAMPAGNE APOTHECARY LLC365ca99c-c878-1f4b-e063-6394a90a1f532025-12-16Exact identifier
application number: M020
Tinted Mineral Defense SPF 40ZINC OXIDEJOSEPHINA RAMIREZ365d299a-5886-5597-e063-6394a90a336c2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILL VALLEY DERMATOLOGY, INC.3b171a89-c757-47a1-e063-6294a90a7a642025-12-16WarningsExact identifier
application number: M020
Tinted BB CreamZINC OXIDEEco Esthetics LLC38f3e618-59e1-4504-e063-6394a90afa552025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEMADRE TIERRA, INC.3f697463-d3db-7b73-e063-6394a90ac2222025-12-16WarningsExact identifier
application number: M020
Non-Tinted Replenishing Daily ProtectionZINC OXIDEMADRE TIERRA, INC.3f69d6f3-454b-e60a-e063-6394a90a87812025-12-16WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDEISIS GONZALEZ3f68b2ea-be23-100d-e063-6294a90a8b372025-12-16WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDEISIS GONZALEZ3f682b78-e1c9-e174-e063-6294a90a17ed2025-12-16WarningsExact identifier
application number: M020
Silk Screen TintedTITANIUM DIOXIDE, ZINC OXIDESkin Science Institute Inc36c3793a-ccb5-1e5f-e063-6294a90ad44f2025-12-16Exact identifier
application number: M020
Silk Screen TintedTITANIUM DIOXIDE, ZINC OXIDESkin Science Institute Inc36c3a721-6be1-3f7f-e063-6394a90a522f2025-12-16Exact identifier
application number: M020
True Tone TintedTITANIUM DIOXIDE, ZINC OXIDEThat Face PLLC36c2bb0e-479d-89cd-e063-6294a90aa3d42025-12-16Exact identifier
application number: M020
True Tone Non TintedZINC OXIDEThat Face PLLC36c2f263-67cf-e8cf-e063-6394a90ad81f2025-12-16Exact identifier
application number: M020
Tinted Daily Protection SunscreenZINC OXIDEKemmi Lee Skin Science37ef5a05-54d2-a8e4-e063-6394a90a8e482025-12-16Exact identifier
application number: M020
Aquaphor Lip Repair Stick and SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Incd469bddf-90d4-7b1c-e053-2a95a90a1ed92025-12-16WarningsExact identifier
application number: M020
Eucerin Daily Protection FaceENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEBeiersdorf Inc76403f03-aee9-4c0b-b331-f79b6953118c2025-12-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73496-014-017349600140150 mL in 1 BOTTLE, PUMP (73496-014-01) 50 ml2025-12-08NoNoCurrent
73496-014-027349600140250 mL in 1 TUBE (73496-014-02) 50 ml2025-03-252028-03-31NoNoHistorical