FDA.reportPublic FDA data

Lycogel Breathable Balm

Manufacturer
Quura Medical B.V | Allure Cosmetic Inc.
Effective date
2018-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:54

Label at a glance#

ProductLycogel Breathable Balm
Active ingredientOCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure4 sections

Label contents#

Full prescribing information#

Actives

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE,OXYBENZONE,OCTISALATE and AVOBENZONE

Inactives

INACTIVE INGREDIENT SECTION

Water (Aqua)

C12-15 Alkyl Benzoate

Octinoxate

Oxybenzone

Octisalate

Butylene Glycol

Octyldodecyl Neopentanoate

Caprylic/Capric Triglyceride

Avobenzone

Octocrylene

Glycerin

Sodium Hyaluronate

Camellia Sinensis Leaf Extract

Teprenone

Cyclopentasiloxane

Cyclohexasiloxane

Actinidia Chinensis (Kiwi) Fruit Extract

Algae Extract

Artemisia Vulgaris Extract

Saccharomyces Lysate Extract

Centella Asiatica Extract

Echinacea Purpurea Extract

Yeast Polysaccharides

Carbomer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

PEG-8

Triethanolamine

Phenoxyethanol

Caprylyl Glycol

Ethylhexylglycerin

Hexylene Glycol

Tocopherol

Ascorbyl Palmitate

Citric Acid

Zinc PCA

Mannitol

Lonicera Japonica (Honeysuckle) Flower Extract

Sodium Citrate

Xanthium Sibiricum Fruit Extract

Aloe Barbadensis Leaf Extract

Cyperus Rotundus Root Extract

Acetyl Tetrapeptide-15

Sodium Benzoate

Sorbitan Oleate

Polysorbate 20

Palmitoyl Pentapeptide-4

Arctostaphylos Uva Ursi Leaf Extract

Plankton Extract

Mitracarpus Scaber Extract

Olea Europaea (Olive) Leaf  Extract

Darutoside

Xanthan Gum

Micrococcus Lysate

Arabidopsis Thaliana Extract

Ubiquinone

Hydroxydecyl Ubiquinone

Disodium EDTA

Phospholipids

Retinyl Palmitate

Beta-Carotene

Ascorbic Acid

Malus Domestica Fruit Cell Culture Extract

Lecithin

Tube Label 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product labelproduct label

Tube label 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51790-400-012024-01-30C16284748780-11030e365-571d-111a-e063-dadaa90a10e246e854cb-6694-4e57-b6e4-15684dfab80b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51790-400-01Lycogel Breathable Balm60 mL in 1 TUBECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51790-400LYCOGEL BREATHABLE BALM (OCTINOXATE,OXYBENZONE,OCTISALATE AND AVOBENZONE) CREAM [QUURA MEDICAL B.V]1Legacy NDC, 1 package rows20180101_46e854cb-6694-4e57-b6e4-15684dfab80b.zip

Products#

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

DailyMed product names page 1 of 2 · 60 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51790-40051790-400-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 58 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TEPRENONES8S8451A4OIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
CYCLOMETHICONE 4CZ227117JEIACT
KIWI FRUIT71ES77LGJCIACT
CHLORELLA VULGARISRYQ4R60M02IACT
ARTEMISIA VULGARIS WHOLEJDR81QW9ZQIACT
SACCHAROMYCES LYSATER85W246Z1CIACT
CENTELLA ASIATICA7M867G6T1UIACT
ECHINACEA PURPUREAQI7G114Y98IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TROLAMINE9O3K93S3TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ZINC PIDOLATEC32PQ86DH4IACT
MANNITOL3OWL53L36AIACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
SODIUM CITRATE1Q73Q2JULRIACT
XANTHIUM SIBIRICUM FRUIT3H333L84C2IACT
ALOE VERA LEAFZY81Z83H0XIACT
CYPERUS ROTUNDUS TUBER4B51SRR959IACT
ACETYL TETRAPEPTIDE-156K389LE0MVIACT

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
c289d903-04fe-4055-a9ef-45835981e03146e854cb-6694-4e57-b6e4-15684dfab80b2018-01-01Exact identifier
spl id: c289d903-04fe-4055-a9ef-45835981e031
spl set id: 46e854cb-6694-4e57-b6e4-15684dfab80b

Reported adverse events (FAERS/openFDA)#

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