FDA.reportPublic FDA data

BioBarrier Renewal Cream

Manufacturer
bluemercury
Effective date
2024-09-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:19:37

Label at a glance#

ProductBioBarrier Renewal Cream
Active ingredientALLANTOIN
Label structure9 sections

Dosage and administration

Directions Apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

m-61

powerful skincare

BioBarrier

Renewal

Cream

RENEWING

NUTRIENT-RICH

TRIPLE CERAMIDE

AND ALLANTOIN

CUSHION CREAM

Advanced triple ceramide
renewal treatment
with 0.75% allantoin,
essential fatty acids and
plant-derived squalane

all skin types

100% paraben-free
100% synthetic fragrance-free
dermatologist tested
allergy tested

1.7 Oz. / 50 g

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Allantoin 0.75%

Purpose

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

  • Temporarily protects minor cuts, scrapes, burns
    • Helps prevent and temporarily protects and helps relieve chaged, chapped, or cracked skin

WARNINGS

WARNINGS SECTION

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Conition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

OTC - DO NOT USE SECTION

Do not use on

  • Deep or puncture wounds
  • Animal bites
  • Serious burns.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Hydrogenated Didecene, Coco-Caprylate/Caprate, Glyceryl Stearate SE, Oenothera Biennis (Evening Primrose) Oil, Squalane, Rhus Verniciflua (Varnish Tree) Peel Wax, Cetearyl Olivate, Saccharomyces Ferment Filtrate, Cetearyl Glucoside, Sorbitan Olivate, Ceramide NP, Ceramide AP, Cholesterol, Ceramide EOP, Phytosphingosine, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate, Sodium Gluconate, Sodium Stearoyl Glutamate, Carbomer, Sodium Lauroyl Lactylate, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin.

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?
800-294-7700 9-5pm EST, Monday-Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioBarrier Renewal Cream CartonBioBarrier Renewal Cream CartonBioBarrier TubeBioBarrier Tube

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72203-019-01BioBarrier Renewal Cream50 g in 1 TUBECREAM502
72203-019-02BioBarrier Renewal Cream1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72203-019BIOBARRIER RENEWAL CREAM (ALLANTOIN) CREAM [BLUEMERCURY]2Current NDC, 2 package rows20240918_1ee15f84-0561-3cd2-e063-6394a90ab68e.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72203-01972203-019-01, 72203-019-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
HYDROGENATED DIDECENE048B98MT5OIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX6RG2461FCHIACT
CETEARYL OLIVATE58B69Q84JOIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CERAMIDE NP4370DF050BIACT
CHOLESTEROL97C5T2UQ7JIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SORBITAN OLIVATEMDL271E3GRIACT
SODIUM GLUCONATER6Q3791S76IACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SQUALANEGW89575KF9IACT
CERAMIDE APF1X8L2B00JIACT
ALLANTOIN344S277G0ZACTIB
SACCHAROMYCES CEREVISIAE978D8U419HIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CERAMIDE 15THT33P7X7IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
BioBarrier Renewal CreamALLANTOINbluemercury1ee15f84-0561-3cd2-e063-6394a90ab68e2024-09-15WarningsExact identifier
ndc (package): 72203-019-02
ndc (package): 72203-019-01
ndc (product): 72203-019
ndc11 (package): 72203001901
ndc11 (package): 72203001902
spl id: 222d037c-6c17-07ee-e063-6394a90a496d
spl set id: 1ee15f84-0561-3cd2-e063-6394a90ab68e

Reported adverse events (FAERS/openFDA)#

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