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 241 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.0166d193-fc4d-51f7-e063-6294a90aaf322025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e831a1-c82f-3e1f-e053-2a95a90ae1f62025-01-01WarningsExact identifier
application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e82b4e-ce84-0ca2-e053-2a95a90a88de2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.016798a8-4275-47d0-e063-6294a90a5aca2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.f1166cb4-b471-7043-e053-2a95a90a7fa72025-01-01WarningsExact identifier
application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.f8361aa8-c3ad-0c47-e053-6394a90a6ab02025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6807577-56a1-a40c-e053-2995a90a59352025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.0289088d-3316-c90c-e063-6294a90a69e02025-01-01WarningsExact identifier
application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.a4364c8d-8b74-130e-e053-2995a90ad1c12025-01-01WarningsExact identifier
application number: M020
b.tan Tropic Like Its Hot SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarque of Brands Americas, LLCbb15b1bc-cfc0-0bab-e053-2a95a90af5b32025-01-01WarningsExact identifier
application number: M020
Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMDTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLCff95a7b7-3cb4-41b0-866d-69361354a0bc2025-01-01WarningsExact identifier
application number: M020
Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 SUNSCREENAVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONEObagi Cosmeceuticals LLC84f0f1dd-13f2-49f5-89b3-fab175ac25642025-01-01WarningsExact identifier
application number: M020
NU-DERM HEALTHY SKIN PROTECTION SPF 35OCTINOXATE AND ZINC OXIDEObagi Cosmeceuticals LLCcfb6a918-1403-4cf2-86d8-d66dd764bb6c2025-01-01WarningsExact identifier
application number: M020
CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENELaboratoires Clarinsc6dffe5c-5539-4e86-bf5e-b0e497eb9c882024-12-31WarningsExact identifier
application number: M020
Badger Adventure Sport Clear Mineral Sunscreen SPF 50ZINC OXIDEW.S. Badger Company, Inc.d10290b4-3c8a-e0bb-e053-2995a90a9b6b2024-12-31WarningsExact identifier
application number: M020
Badger BROAD SPECTRUM SPF 15 Lip BalmZINC OXIDEW.S. Badger Company, Inc.d506ac39-5019-1291-e053-2995a90a796a2024-12-31WarningsExact identifier
application number: M020
Badger Kids Mineral Sunscreen Cream Broad Spectrum SPF 40ZINC OXIDEW.S. Badger Company, Inc.d619d2b4-bae8-bc76-e053-2995a90a369b2024-12-31WarningsExact identifier
application number: M020
Badger SPF 35 Kids Clear Face StickZINC OXIDEW.S. Badger Company, Inc.d1038442-ec86-07e3-e053-2995a90ad6ab2024-12-31WarningsExact identifier
application number: M020
Badger Baby Sunscreen Cream Broad Spectrum SPF 40ZINC OXIDEW.S. Badger Company, Inc.d61acaa0-73ef-eccf-e053-2995a90ad9402024-12-31WarningsExact identifier
application number: M020
Badger Broad Spectrum SPF 35 Active Face StickZINC OXIDEW.S. Badger Company, Inc.d61b0dc8-3864-d5e3-e053-2a95a90ac02f2024-12-31WarningsExact 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