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 289 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior105651f2-3c99-4ff3-b67b-350a40dc88882024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7b1b551b-e78d-47ff-bb91-0d5f676c73fc2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2411e8e6-a958-4fd9-b5e9-b9a32020ce542024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior062f61d2-a9a7-46e1-92e4-a6bdf257c1882024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9c3d513f-8331-4155-a77b-c358093a607c2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7f8d1d0-1734-46a5-82fe-b0ac140175222024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3COCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc3849d5c-4f91-4147-aeb2-7461a3a943092024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4COCTISALATE, TITANIUM DIOXIDEParfums Christian Diore8f29488-10f8-4df6-b1f5-d9a670f60fca2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior86e0d1e4-3207-49e6-b5fa-e63f4ca300db2024-08-06WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd67b009-accc-6c7b-e053-6294a90ad80e2024-08-06WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Continuous SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.fd67fa5d-f997-c607-e053-6294a90aee2b2024-08-06WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd66ee9b-5a24-776a-e053-6294a90a65592024-08-06WarningsExact identifier
application number: M020
SANTO REMEDIOS RADIANCE SILKY MINERAL PRIMER SUNSCREEN SPF 42 IVORYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC0708ec87-16c4-412b-971b-d4572931c7802024-08-05WarningsExact identifier
application number: M020
EltaMD UV Physical SPF41ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc8fdc04eb-4079-40e3-a1b3-be4a542cf99a2024-08-05WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.6377c0f7-e2cb-44f0-9786-42c5a9d02f882024-08-04WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion LightTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.e98696d2-7f7f-4a4c-b8ae-849f2d211a042024-08-04WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.f31842f7-3474-4462-87e2-c4ebde97a5832024-08-04WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.ccfafefc-fff4-41ff-baf4-3f430c690be72024-08-04WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF50ZINC OXIDEThe Hain Celestial Group, Inc.f4a02196-288e-1958-e053-2a95a90a53052024-07-31WarningsExact identifier
application number: M020
Very Emollient Body Daily Shade SPF15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Hain Celestial Group8eeb25a8-337d-c71b-e053-2995a90a091a2024-07-31WarningsExact 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