FDA.reportPublic FDA data

PURE SOL SPF15 Lip Gloss original

Manufacturer
Brand 2022b LLC
Effective date
2025-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:56

Label at a glance#

ProductPURE SOL SPF15 Lip Gloss original
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 7.2%

OTC - PURPOSE SECTION

Helps prevent sunburn.

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.

WARNINGS SECTION

For external use only

When using this product keep out of eyes.

Rinse with water to remove - do not use on broken skin.

INDICATIONS & USAGE SECTION

Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two hours.

■Sun Protection Measures: Spending time in the sun increases

your risk of skin cancer and early skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum SPF value of 15

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two hours.

INACTIVE INGREDIENT SECTION

POLYISOBUTENE
TRIDECYL TRIMELLITATE
PHENYL METHICONE
C12-15 ALKYL BENZOATE
CETYL DIMETHICONE
ETHYLHEXYL PALMITATE
SILICA
TRIETHOXYCAPRYLYLSILANE
CETYL PEG/PPG-10/1 DIMETHICONE
PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE
CERA MICROCRISTALLINA
PARAFFIN
STEARYL DIMETHICONE
TRIBEHENIN
CERA MICROCRISTALLINA
FLAVOR
SILICA DIMETHYL SILYLATE
CI 77019
CI 77491
DISTEARDIMONIUM HECTORITE
WATER
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
SORBITAN ISOSTEARATE
TOCOPHERYL ACETATE
CI 77891
CI 75470
BHT
CI 45370

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84090-006-01PURE SOL SPF15 Lip Gloss original4 mL in 1 TUBELIQUID41

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
84090-00684090-006-01

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
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BHT1P9D0Z171KIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
STEARYL TRIMETHICONE796MG354ZZIACT
CI 75470CID8Z8N95NIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SILICAETJ7Z6XBU4IACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
CI 453707MF02AWG95IACT
TRIBEHENIN8OC9U7TQZ0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ZINC OXIDESOI2LOH54ZACTIB
HYDROGENATED POLYISOBUTENE 87YR4ZFS62EIACT
PHENYL METHICONE (500 CST)5T0F958X3ZIACT
WATER059QF0KO0RIACT
CI 7789115FIX9V2JPIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
CI 774911K09F3G675IACT
FLAVOR SPICE MINT N&A110589KG6KU384XWIACT
MICAV8A1AW0880IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
ETHYLHEXYL PALMITATE2865993309IACT
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE255PIF62MSIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMERAE7QA6TW0QIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
PARAFFINI9O0E3H2ZEIACT

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
PURE SOL SPF15 Lip Gloss originalZINC OXIDEBrand 2022b LLC4056e49a-2976-38f9-e063-6394a90a786d2025-10-04WarningsExact identifier
ndc (package): 84090-006-01
ndc (product): 84090-006
ndc11 (package): 84090000601
spl id: 4056e49a-2977-38f9-e063-6394a90a786d
spl set id: 4056e49a-2976-38f9-e063-6394a90a786d

Reported adverse events (FAERS/openFDA)#

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