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 262 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e98c3b64-edcb-16c7-e053-2a95a90a8a0e2024-12-04WarningsExact identifier
application number: M020
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
application number: M020
sunscreen 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f82024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 21ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9585d3d2-806c-36e3-e053-2a95a90a28fa2024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB SPF42 No21OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3d196cf3-eddd-21d7-e054-00144ff88e882024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 23ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.6a81522e-f4d9-4013-8563-f50f01ff63262024-12-04WarningsExact identifier
application number: M020
Milani Prime Protect SPF 30 Face PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONEThe Milani Group, Inc.d557d554-5161-482c-bd78-7721c7dc9a6e2024-12-04WarningsExact identifier
application number: M020
Pipette Diaper RashZINC OXIDEAmyris, Incef5ea6f5-0126-47de-9bee-9070c5f6112b2024-12-04WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc81a889b8-0719-40c9-b8d4-d9220747ce492024-12-04WarningsExact identifier
application number: M020
Bright-eyed 100% mineral Eye Cream Broad Spectrum Sunscreen SPF 40ZINC OXIDESupergoop, LLC971ac413-5e69-7553-e053-2995a90a41682024-12-04WarningsExact identifier
application number: M020
PLAY Antioxidant Body Mist SPF 50 With Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC9c5c0608-3f42-6640-e053-2a95a90a50862024-12-04WarningsExact identifier
application number: M020
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S Ae4bb5a32-c5dc-86d5-e053-2a95a90a49382024-12-04WarningsExact identifier
application number: M020
Burts Bees Firming Day SPF30ZINC OXIDEBurts Beesf028ffea-184b-46db-9e48-dab4a535bf002024-12-03WarningsExact identifier
application number: M020
Burts Bees Calming Day SPF30ZINC OXIDEBurts Beese406e6ba-fa6d-452d-bc29-404e2f8fcf3e2024-12-03WarningsExact identifier
application number: M020
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen AmberZINC OXIDE, TITANIUM DIOXIDEAlumier Labsba864a08-e66d-d286-e053-2995a90a18542024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs2874e531-d647-339c-e063-6394a90ac86f2024-12-03WarningsExact identifier
application number: M020
REEF SAFE Unscented SPF Mineral Sunscreen 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.286965aa-0961-0141-e063-6394a90aa3f02024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer Hydration Tinted Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa951ebe7-7786-38ef-e053-2995a90a70e32024-12-03WarningsExact 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