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 316 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5169b10e-5a8d-479a-a6a8-1e7a13cb70c42023-12-12WarningsExact identifier
application number: M020
Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20TITANIUM DIOXIDEBoscia LLCf76166f1-e987-4eaf-8192-14dc08c481f72023-12-12WarningsExact identifier
application number: M020
Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBoscia LLC2a6b507f-0967-46e1-8360-0003772f1bdb2023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily SkinOCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporated97bd2033-2cf0-4e5d-81e2-c453a1e3a65e2023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 01TITANIUM DIOXIDE3LAB, Inc.703dc828-24b4-4f04-9f2c-4a2edfdf46322023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02TITANIUM DIOXIDE3LAB, Inc.7c6c7062-91f7-4304-98c3-f77967a2d3292023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry SkinOCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporated8a75dde9-8dcb-4f4a-b9df-88338bd2a4402023-12-12WarningsExact identifier
application number: M020
Everyday Facial Moisturizer And Sunscreen SPF 20ZINC OXIDE714 Essentials LTD3a29018b-8103-4983-b0c5-5f340775a05d2023-12-12WarningsExact identifier
application number: M020
Likewise Hand Moisturizer - Sun Protectant SPF 50OCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporateda54f0854-c55e-4a46-9084-16cb1be0f6812023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 01TITANIUM DIOXIDE3LAB, Incbd39d2fb-8326-4e19-b634-7a7308313d8a2023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 03TITANIUM DIOXIDE3LAB, Inc19884289-edb2-4d18-bd62-873533b94a102023-12-12WarningsExact identifier
application number: M020
Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.92dc1a86-590e-4144-9d30-172645e631402023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 02TITANIUM DIOXIDE3LAB, Incbf4419b9-408d-469a-aa15-bbf419632f022023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT Sunscreen SPF 50 Plus Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE3LAB, Inc2bee6b87-c889-4ea1-87ad-e28949bcb67a2023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily SkinTITANIUM DIOXIDE, ZINC OXIDELikewise Incorporated28b8c519-8417-427e-8d4f-94da44a69d9f2023-12-12WarningsExact identifier
application number: M020
BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c795f0-63bc-3033-e053-2995a90a55ab2023-12-12WarningsExact identifier
application number: M020
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.c06ecc56-2044-4396-8acd-6d18af9b984c2023-12-12WarningsExact identifier
application number: M020
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.f5c7b7ce-b3ed-3e96-e053-2995a90a8ea92023-12-12WarningsExact identifier
application number: M020
Milani SPF BFF 30 PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONENew Milani Group, LLCc7a1f2a7-d299-2116-e053-2995a90ad8c52023-12-12WarningsExact identifier
application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENew Milani Group, LLC8f52f614-1cfe-4ef0-8cb6-37afbfddf44c2023-12-12WarningsExact 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