FDA.reportPublic FDA data

Really Great Lip Shield

Manufacturer
JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:25:51

Label at a glance#

ProductReally Great Lip Shield
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385585212452GTIN-13: 0385585212452
EAN-13: 0385585212452
GTIN-12: 385585212452
UPC-A: 385585212452
GTIN storage (14 digits): 00385585212452		roth 212.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85585-212-45Really Great Lip Shield4.5 g in 1 CYLINDERSTICK4.52
85585-212-45Really Great Lip Shield1 in 1 CARTONSTICK12

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85585-21285585-212-45
58892-212

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
ZINC OXIDESOI2LOH54ZACTIB
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CETYL DIMETHYLBUTYL ETHER7LAB1GXG9GIACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
PEG/PPG-15/15 DIMETHICONE184IZ28A2GIACT
SOYBEAN LECITHIN1DI56QDM62IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CITRIC ACID2968PHW8QPIACT
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTERR6G12EY23XIACT
CI 77492EX438O2MRTIACT
CERESINQ1LS2UJO3AIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
ALUMINALMI26O6933IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
CI 77499XM0M87F357IACT
TOCOPHEROLR0ZB2556P8IACT
PEG-8B697894SGQIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
ETHYLHEXYL PALMITATE2865993309IACT
HEXYLDECANOL151Z7P1317IACT
CI 774911K09F3G675IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
HEXYLDECYL LAURATE0V595C1P6MIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ASCORBIC ACIDPQ6CK8PD0RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Really Great Lip ShieldTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c1341d-fbf5-56a5-e063-6294a90aa0452025-12-16Exact identifier
ndc (package): 85585-212-45
ndc (product): 85585-212
ndc11 (package): 85585021245
spl id: 46163558-0bb6-6edb-e063-6294a90a36ff
spl set id: 36c1341d-fbf5-56a5-e063-6294a90aa045
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
ndc (product): 58892-212

Reported adverse events (FAERS/openFDA)#

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