FDA.reportPublic FDA data

g and h Protect Body

Product NDC
10056-025
11-digit product format
100560025
Labeler code
10056
Product ID
10056-025_085bcc1d-8ef6-1348-e063-6394a90af6cf
Type
HUMAN OTC DRUG
Nonproprietary name
ENSULIZOLE, OCTISALATE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Access Business Group LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-10
Substance
ENSULIZOLE; OCTISALATE; ZINC OXIDE
Active strength
17; 50; 165.55 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
g and h Protect Body
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENSULIZOLE17 mg/mL
OCTISALATE50 mg/mL
ZINC OXIDE165.55 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9YQ9DI1W42Internal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03768ff4-0c67-48b3-a2f3-321d0a6790e8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10056-025-00g and h Protect Body100 mL in 1 TUBELOTION1004
10056-025-00g and h Protect Body1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10056-025G AND H PROTECT BODY (ENSULIZOLE, OCTISALATE, ZINC OXIDE) LOTION [ACCESS BUSINESS GROUP LLC]4Current NDC, 2 package rows20231023_03768ff4-0c67-48b3-a2f3-321d0a6790e8.zip

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 170 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7163861-7084-5adf-e053-2995a90ae1992025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 8OCTINOXATE AND OXYBENZONETropical Seas, Inc.b5fa2883-998f-2128-e053-2995a90a5c842025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 15OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b557c9c5-6ea8-1d59-e053-2995a90aff682025-11-04WarningsExact identifier
application number: M020
Vertra Ehukai Beige Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b71619c4-a8ef-1dda-e053-2995a90aba502025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 45OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATETropical Seas, Inc.b4cafdf1-44e1-10c0-e053-2995a90ab3dc2025-11-04WarningsExact identifier
application number: M020
Reef Kids SPF 30 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.e226b07a-9f44-4b17-8f26-c86dcfa5dcda2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b4cc95f0-d684-5331-e053-2995a90a32952025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 20OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b55792e6-2ead-1fb1-e053-2995a90ac9152025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 8OCTINOXATE AND OXYBENZONETropical Seas, Inc.b5e68448-4131-1c6c-e053-2a95a90a014a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 40ZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d204c38c-b5d1-3511-e053-2a95a90a9dc82025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e4e63c-3e51-0a78-e053-2a95a90abd872025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.8cd68b09-2578-4519-b00e-e83e0e4408152025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e44be7-3a46-34e2-e053-2a95a90a96602025-11-04WarningsExact identifier
application number: M020
Reef Kids SPF 30 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.005a9e7c-e392-4b9a-911f-d7586f7ae94e2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559d349-2ffd-492c-e053-2995a90aab062025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pink BeachZINC OXIDETropical Seas, Inc.d240e6c9-d053-9924-e053-2a95a90a855a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 15OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e49c6f-477b-aafc-e053-2a95a90a982a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559e03b-f5d3-bd72-e053-2995a90a31ca2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Clear ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d128269b-73fa-e5f3-e053-2995a90af1ed2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50 SportOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e40a7c-b49d-cfc3-e053-2995a90ac27e2025-11-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10056-025-00100560025001 TUBE in 1 CARTON (10056-025-00) / 100 mL in 1 TUBE1 tube2023-07-10NoNoCurrent