FDA.reportPublic FDA data

RoC Hydration Plus SPF 30

Product NDC
73496-014
Requested package NDC
73496-014-01
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 109 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bella Blue Skin Care Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f663fe5-fdfe-d793-e063-6394a90a4f0b2025-12-17WarningsExact identifier
application number: M020
Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3aadc018-edbb-033b-e063-6394a90afbe72025-12-17WarningsExact identifier
application number: M020
Non-Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3ab0298d-b2d0-591e-e063-6394a90a31772025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3cce3120-748e-a7fd-e063-6394a90a4d512025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3ccea6c0-8c27-6b26-e063-6294a90a09312025-12-17WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEJKH Aesthetics LLC369c1d16-5980-e1dc-e063-6394a90a31042025-12-17Exact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3d5a2662-02e3-3a95-e063-6294a90a81202025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3d5ab3f6-10b9-2a21-e063-6294a90a34282025-12-17WarningsExact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJKH Aesthetics LLC369ccb8f-d9b6-1fd2-e063-6394a90ace202025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364cafdd-fe86-cb23-e063-6394a90afb092025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364d2231-3db3-0a59-e063-6394a90a67772025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d69eb5-597d-14a0-e063-6394a90a0a492025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
application number: M020
Gentle Mineral SPF 40 TintedZINC OXIDEELIZA ARAKELIAN36d66cde-1f90-32b5-e063-6294a90acb342025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d7148b-b1c4-a6a9-e063-6294a90af92f2025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
application number: M020
DAY DEFENSETITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad1330-a8bf-e8f8-e063-6394a90acb022025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d9a8f3-7760-57f3-e063-6394a90a1a1e2025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d7a18b-5a12-84a9-e063-6394a90a7e382025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73496-014-017349600140150 mL in 1 BOTTLE, PUMP (73496-014-01) 50 ml2025-12-08NoNoCurrent