FDA.reportPublic FDA data

HydroScreen

Manufacturer
METHODIQ INC.
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:14

Label at a glance#

ProductHydroScreen
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. TO decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection meas...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 12%, Octisalate 4.8%, Octocrylene 4.5%, Avobenzone 2.8%

Purpose

OTC - PURPOSE SECTION

Homosalate 12%, Octisalate 4.8%, Octocrylene 4.5%, Avobenzone 2.8%..................Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product Keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. TO decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limited time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirt, pants, hats, and sunglasses.

Other Information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dipropylene Glycol, Cyclopentasiloxane, NIacinamide, Butyloctyl Salicylate, Cyclohexasiloxane, Pentylene Glycol, Polymethylsilsesquioxane, Silica, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Methylpropanediol, Butylene Glycol, Betaine, Panthenol, 1,2-Hexanediol, Xanthan Gum, Acacia Senegal Flower/Stem Extract, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Caprylyl Glycol, Adenosine, Glycerin, Pyrus Communis (Pear) Fruit Extract, Rosa Damascena Flower Water, Mangifera Indica (Mang) Fruit Extract, Allantoin, Iris Florentina Root Extract, Ethyl Hexanediol, Cucumis Melo (Melon) Fruit Extract, Hydrolyzed Extensin, Hydrogenated Extensin, Hydrogenated Lecithin, Steareth-30, Hedera Helix (Ivy) Leaf/Stem Extract, Cetearyl Alcohol, Melia Azadirachta Leaf Extract, Stearic Acid, Narcissus Tazetta Extract, Tuber Magnatum Extract, Hydrolyzed Collagen, Ceramide NP, Cholesterol, Phytosphingosine, Ceramide NG, Ceramide NS, Ceramide AS, Ceramide AP, Collagen Extract, Ceramide EOP, Sodium Polyphosphate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10ml

0.3 Fl. Oz. e

HydroScreen

Broad Spectrum SPF 30 Sunscreen

Niacinamide, Hydrolyzed Collagen, Ceramides, Allantoin

Apply generously and evenly 15 minutes before sun exposure.

11

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87110-00587110-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE 2208 0.45% STEAROXY ETHERMG58AH4FJ8IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HEDERA HELIX LEAFZP9XFG71A7IACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
BETAINE3SCV180C9WIACT
PANTHENOLWV9CM0O67ZIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
CHOLESTEROL97C5T2UQ7JIACT
CERAMIDE APF1X8L2B00JIACT
PYRUS COMMUNIS (PEAR) FRUIT2ZN8DWC0YFIACT
MANGIFERA INDICA (MANGO) FRUITI629I3NR86IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CERAMIDE NGC04977SRJ5IACT
ETHYL HEXANEDIOLM9JGK7U88VIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MUSKMELONZV095H5633IACT
NARCISSUS TAZETTA BULBK17762966SIACT
CERAMIDE NSV7M2259XJMIACT
IRIS FLORENTINA ROOTM30XO5X4XDIACT
XANTHAN GUMTTV12P4NEEIACT
HOMOSALATEV06SV4M95SACTIB
PEG-100 STEARATEYD01N1999RIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
NIACINAMIDE25X51I8RD4IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
PENTYLENE GLYCOL50C1307PZGIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ACACIA SENEGAL FLOWER72P931MTC2IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ADENOSINEK72T3FS567IACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
ALLANTOIN344S277G0ZIACT
MELIA AZADIRACHTA LEAFHKY915780TIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydroScreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMETHODIQ INC.4c9d5dfd-d790-fffc-e063-6294a90a4d302026-03-09WarningsExact identifier
ndc (package): 87110-005-01
ndc (product): 87110-005
ndc11 (package): 87110000501
spl id: 4c9d5dfd-d791-fffc-e063-6294a90a4d30
spl set id: 4c9d5dfd-d790-fffc-e063-6294a90a4d30