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 161 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Riversol Daily Glow Mineral UntintedZINC OXIDERiversol Skincare3bc78cbb-83e3-7fd6-e063-6394a90a52602025-11-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC236d2dce-70aa-66d2-e063-6394a90aff522025-11-17WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Dusky Pink 8gZINC OXIDENAKED SUNDAYS PTY LTD2f441311-b41c-d4e8-e063-6394a90a697a2025-11-17WarningsExact identifier
application number: M020
Woro Beauty SPFortlessTITANIUM DIOXIDE, ZINC OXIDEWoro Beauty3d86ef02-c947-2791-e063-6394a90a42cc2025-11-17WarningsExact identifier
application number: M020
Dolce Glow Body BalmZINC OXIDEDolce Glow, Inc.43cea601-a6c0-4de3-e063-6294a90aa8eb2025-11-17WarningsExact identifier
application number: M020
Hello Sunday The One For Your Lips Clear Lip Balm SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c92dfc3-782d-e11f-e063-6394a90a2f8a2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d506dd-4103-de3c-e063-6294a90ac1902025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5174f-6bd2-1294-e063-6294a90a407b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5299f-6273-30ab-e063-6294a90a082e2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d53bac-560d-6e4d-e063-6394a90a40c42025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d55c3d-4550-8131-e063-6394a90a0eed2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d56169-4843-8546-e063-6294a90a8a102025-11-17WarningsExact identifier
application number: M020
BRING GREEN TEA TREE CICA SUN CUSHIONZINC OXIDE, TITANIUM DIOXIDECJ Olive Young Corporation30850a56-6438-dbe1-e063-6294a90a6d9f2025-11-17WarningsExact identifier
application number: M020
BRING GREEN TEA TREE CICA SUNCREAMZINC OXIDECJ Olive Young Corporation30bdb3c6-2bfa-87c2-e063-6394a90a9a432025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c73747-82b6-c71c-e063-6294a90aea522025-11-17WarningsExact identifier
application number: M020
Arnies Mineral Sunscreen - Broad Spectrum SPF 50 with Zinc OxideZINC OXIDEGimmie Botanicals LLC43e24a9a-a25c-f011-e063-6394a90abbb22025-11-17WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Pink Pop 8gZINC OXIDENAKED SUNDAYS PTY LTD2f46049b-7e81-9c7e-e063-6394a90a8f492025-11-14WarningsExact identifier
application number: M020
Huey Daily MineralTITANIUM DIOXIDE, ZINC OXIDEHuey15bdf9c6-3bfa-4eef-e063-6294a90a195f2025-11-14WarningsExact identifier
application number: M020
Pipette Diaper RashZINC OXIDEPipette LLC2a93998c-1855-9207-e063-6294a90ab0e92025-11-14WarningsExact identifier
application number: M020
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact 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