FDA.reportPublic FDA data

g&h Protect Body Lotion

Manufacturer
Access Business Group LLC
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:16

Label at a glance#

Productg and h Protect Body
Active ingredientENSULIZOLE, OCTISALATE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating Reapply at least every 2 hours  Children under 6 months: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ensulizole 1.700%

Octisalate 5.000%

Zinc Oxide 16.555%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on broken or damaged skin

When using this product

OTC - WHEN USING SECTION

kep out of eyes. Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours 
  • Children under 6 months: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylheptyl Caprylate, Propanediol, Hexyl Laurate, Acrylates Copolymer, Caprylyl Methicone, Diphenylsiloxy Phenyl Trimethicone, Ethylhexyl Palmitate, Alcohol Denat., Polyglyceryl-4, Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Tromethamine, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Stearalkonium Hectorite, Triethoxycaprylylsilane, Poly C10-30 Alkyl Acrylate, Fragrance/Parfum, Magnesium Sulfate, Butylene Glycol, Chlorella Vulgaris Extract, Disteardimonium Hectorite, Glucose, Polyhydorxystearic Acid, Fructose, Caprylic/Capric Triglyceride, Fructooligosaccharides, Lauric Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Isopropyl Myristate, Isostearic Acid, Lecithin, Xanthan Gum, Polyglyceryl-3 Polyricinoleate, Cynanchum Atratum Extract, Tocopherol, Glechoma Hederacea Extract, Buddleja Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Ethylhexylglycerin, Althaea Rosea Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Centella Asiatica Extract, Limonene, Linalool, Geraniol

Question?

OTC - QUESTIONS SECTION

USA: 1-800-253-6500

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10056-02510056-025-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLHEPTYL CAPRYLATE991Z19V2ODIACT
PROPANEDIOL5965N8W85TIACT
HEXYL LAURATE4CG9F9W01QIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
ETHYLHEXYL PALMITATE2865993309IACT
ALCOHOL3K9958V90MIACT
TROMETHAMINE023C2WHX2VIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHLORELLA VULGARISRYQ4R60M02IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
FRUCTOSE6YSS42VSEVIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LAURIC ACID1160N9NU9UIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOSTEARIC ACIDX33R8U0062IACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
GLECHOMA HEDERACEA WHOLEL6O7WQK912IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALCEA ROSEA FLOWER1250O8MKPZIACT
ROSEMARYIJ67X351P9IACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
GERANIOLL837108USYIACT
ENSULIZOLE9YQ9DI1W42ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
g and h Protect BodyENSULIZOLE, OCTISALATE, ZINC OXIDEAccess Business Group LLC03768ff4-0c67-48b3-a2f3-321d0a6790e82023-10-23WarningsExact identifier
ndc (package): 10056-025-00
ndc (product): 10056-025
ndc11 (package): 10056002500
spl id: 085bcc1d-8ef6-1348-e063-6394a90af6cf
spl set id: 03768ff4-0c67-48b3-a2f3-321d0a6790e8

Reported adverse events (FAERS/openFDA)#

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