FDA.reportPublic FDA data

HydroScreen

Product NDC
87110-005
11-digit product format
871100005
Labeler code
87110
Product ID
87110-005_4c9d5dfd-d791-fffc-e063-6294a90a4d30
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Octocrylene, Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
METHODIQ INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
48; 45; 120; 28 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
HydroScreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE48 mg/mL
OCTOCRYLENE45 mg/mL
HOMOSALATE120 mg/mL
AVOBENZONE28 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c9d5dfd-d790-fffc-e063-6294a90a4d30Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87110-005-01HydroScreen10 mL in 1 TUBECREAM101
87110-005-01HydroScreen1 in 1 CARTONCREAM11

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 313 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coola Bare Republic Mineral Body Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCd745d12e-8741-4bf2-89ec-c6f72a8d548b2023-12-20WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen SPF 70 - Peach BlossomAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC6efa0d9f-0ff3-4b2f-9587-9630261bcbd12023-12-20WarningsExact identifier
application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.b49d5dc5-8d9b-49e4-8d07-d0d6af3fbbdc2023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Face Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCad1614d4-5421-473d-a1e8-0ff18491df772023-12-20WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC4e0e426d-f037-428f-98f2-2d3e945bd0402023-12-19WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Fragrance-Free SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC57f2fdeb-2abc-4ad3-bb89-5faee883c0e52023-12-19WarningsExact identifier
application number: M020
Baby Bare Republic Mineral Sunscreen SoftStick SPF 50ZINC OXIDECOOLA LLC1a603f62-86ec-4e66-a73f-718c5d0126762023-12-19WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Pina Colada SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLCd508cef6-977f-4231-8c19-491569e999212023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - HotZINC OXIDE 15%Bentley Laboratories, LLCa9e7a203-52f0-4a67-b3ea-65ff0968ec182023-12-19WarningsExact identifier
application number: M020
COOLA Refreshing Water Mist SPF 18AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBentley Laboratories, LLC658bf3fe-2246-40b6-8cb1-969bfdaffd1b2023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint Free - CoolZINC OXIDE 15%Bentley Laboratories, LLCcd80661f-348c-4bfd-a85c-041db1a1d0f42023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - WarmZINC OXIDE 15%Bentley Laboratories, LLCd5fd3fea-5dcf-42ef-927a-3b4a3e1ccff82023-12-19WarningsExact identifier
application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutralTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.f5d54e9d-4963-419a-a091-bdbd1decd2b82023-12-19WarningsExact identifier
application number: M020
CHEVOURI Brightening Serum Broad Spectrum SPF-40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECHE'VOURI LLC5a93d5f9-9313-4194-8c39-c513f5a858532023-12-18WarningsExact identifier
application number: M020
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE9598949a-0dd6-4932-9dc8-354f9e10b6012023-12-18WarningsExact identifier
application number: M020
BB blur tinted moisturizer Broad Spectrum SPF 30 lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.207aaa0c-777f-4abd-96b7-64666eb87f532023-12-18WarningsExact identifier
application number: M020
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc69e0d803-be76-4cc3-bdeb-b50401d5d6d42023-12-18WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production8bdd63f7-2f67-4280-9484-d6c8e80ad9b92023-12-16WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8ab49def-c9cd-489e-a936-467067a889402023-12-16WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production0cb8f22d-2343-415e-9f16-1791567864a12023-12-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87110-005-01871100005011 TUBE in 1 CARTON (87110-005-01) / 10 mL in 1 TUBE1 tube2026-04-01NoNoCurrent