FDA.reportPublic FDA data

Dermalogica ® waterblock solar spray spf 30

Manufacturer
Gordon Laboratories, Inc
Effective date
2011-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:09

Label at a glance#

ProductWaterblock Solar SPF 30
Active ingredientHomosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Label structure5 sections

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate (10.0%), Octinoxate (7.5%), Octisalate (5.0%), Octocrylene (10.0%), Oxybenzone (5.0%).

other ingredients

INACTIVE INGREDIENT SECTION

Isododecane, Dicaprylyl Ether, Cyclopentasiloxane, Cocoglycerides, Butyloctyl Salicylate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Diisopropyl Adipate, Melissa Officinalis Leaf Extract, Citrus Grandis (Grapefruit) Peel Oil, Retinyl Palmitate, Ascorbyl Palmitate, Limonene, Tocopheryl Acetate, Caprylyl Glycol.

warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

For external use only, not to be swallowed. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

OTC - STOP USE SECTION

If irritation develops, discontinue use.

OTC - DO NOT USE SECTION

Do not use on infants under 6 months old.

SPL UNCLASSIFIED SECTION

Dermalogica, Dist.
Los Angeles, CA 90009 USA

PRINCIPAL DISPLAY PANEL - 125 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

waterblock
solar spray

spf 30

4.2 FL OZ / 125 ml e

dermalogica®

Principal Display Panel - 125 ml Bottle Carton
Principal Display Panel - 125 ml Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-091-252019-11-13C16284748780-197449f38-cab5-f6ea-e053-dbdaa90aa703Dermalogica ® waterblock solar spray spf 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-091-25Waterblock Solar SPF 301 in 1 BOXLIQUID11
21839-091-25Waterblock Solar SPF 30125 mL in 1 BOTTLE, PLASTICLIQUID1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-091WATERBLOCK SOLAR SPF 30 (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LIQUID [GORDON LABORATORIES, INC]1Legacy NDC, 2 package rows20111117_6f06c25e-350b-4a3c-b034-7db00541e03a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
HomosalateACTIVE MOIETYV06SV4M95S1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
Alpha-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0N1
Butyloctyl SalicylateINACTIVE INGREDIENT2EH13UN8D31
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
Citrus Maxima Fruit Rind OilINACTIVE INGREDIENT8U3877WD441
Coco-glyceridesINACTIVE INGREDIENTISE9I7DNUG1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
Dicaprylyl EtherINACTIVE INGREDIENT77JZM5516Z1
Diisopropyl AdipateINACTIVE INGREDIENTP7E6YFV72X1
IsododecaneINACTIVE INGREDIENTA8289P68Y21
Melissa Officinalis LeafINACTIVE INGREDIENT50D2ZE92191
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVC1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21839-09121839-091-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
HomosalateV06SV4M95SACTIB
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB
IsododecaneA8289P68Y2IACT
Dicaprylyl Ether77JZM5516ZIACT
Cyclomethicone 50THT5PCI0RIACT
Coco-glyceridesISE9I7DNUGIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Diisopropyl AdipateP7E6YFV72XIACT
Melissa Officinalis Leaf50D2ZE9219IACT
Citrus Maxima Fruit Rind Oil8U3877WD44IACT
Vitamin A Palmitate1D1K0N0VVCIACT
Ascorbyl PalmitateQN83US2B0NIACT
Alpha-Tocopherol Acetate9E8X80D2L0IACT
Caprylyl Glycol00YIU5438UIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 19 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XSPRAY / TOPICAL360 mgExact identifier — unii candidate
7 equally ranked IID candidates
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XGEL / TOPICAL150 mgExact identifier — unii candidate
7 equally ranked IID candidates
Alpha-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NCAPSULE / ORAL12 mgExact identifier — unii candidate
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XLOTION / TOPICAL250 mgExact identifier — unii candidate
7 equally ranked IID candidates
Alpha-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XSOLUTION / TOPICAL815 mgExact identifier — unii candidate
7 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSYSTEM / TOPICAL0.04 mgExact identifier — unii candidate
6 equally ranked IID candidates
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XAEROSOL, FOAM / TOPICAL200 mgExact identifier — unii candidate
7 equally ranked IID candidates
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XGEL / TRANSDERMAL1.5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NTABLET / ORAL7.14 mgExact identifier — unii candidate
6 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSUPPOSITORY / RECTAL16 mgExact identifier — unii candidate
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
Alpha-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
Diisopropyl AdipateDIISOPROPYL ADIPATEP7E6YFV72XCREAM / TOPICAL170 mgExact identifier — unii candidate
7 equally ranked IID candidates

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
6f3d5cc8-cae0-47e5-be32-356236a5613f6f06c25e-350b-4a3c-b034-7db00541e03a2011-10-26WarningsExact identifier
spl id: 6f3d5cc8-cae0-47e5-be32-356236a5613f
spl set id: 6f06c25e-350b-4a3c-b034-7db00541e03a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.