FDA.reportPublic FDA data

PURE SOL SPF 37 Tinted Moisturizer

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 SPF 37 Tinted Moisturizer
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 3.84%
TITANIUM DIOXIDE 9.36%

OTC - PURPOSE SECTION

WATER /SWEATRESISTANT
TINTED SPFMOISTURIZER
Shields skin from UVA/UVBBlue Light & Infrared Rodiotion

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away

WARNINGS SECTION

For external use only Do not use on damaged or broken skin.
When using this product: keep out of eyes, Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away
Flammable. Do not spray near heat sparks, sources of ignition, or flames

DOSAGE & ADMINISTRATION SECTION

Apply tiberally 15 minutes before sun exposure.
Reapoly. at least every 2 hours or after 40 minutes of swimming or sweating.

INACTIVE INGREDIENT SECTION

WATER
ALUMINUM HYDROXIDE
STEARIC ACID
CYCLOPENTASILOXANE
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
GLYCERIN
CETYL ETHYLHEXANOATE
DIMETHICONE
TRIETHOXYCAPRYLYLSILANE
CETYL PEG/PPG-10/1 DIMETHICONE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
SILICA
PEG-10 DIMETHICONE
SODIUM CHLORIDE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
CI 77492
ISONONYL ISONONANOATE
CETYL PEG/PPG-10/1 DIMETHICONE
POLYHYDROXYSTEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
WATER
CI 77491
ISONONYL ISONONANOATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
CI 77499
POLYHYDROXYSTEARIC ACID
STYRENE/BUTADIENE COPOLYMER

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure
Reapply
After 40 minutes of swimming or sweating
Immediately after towel drying
At least every 2 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 of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. - 2 p.m.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84090-004-01PURE SOL SPF 37 Tinted Moisturizer30 mL in 1 BOTTLELIQUID301

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
84090-00484090-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
CI 77492EX438O2MRTIACT
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER39DK5WQ2PRIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
STEARIC ACID4ELV7Z65APIACT
CI 774911K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
WATER059QF0KO0RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ZINC OXIDESOI2LOH54ZACTIB
CYCLOPENTASILOXANE0THT5PCI0RIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
DIMETHICONE92RU3N3Y1OIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SILICAETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CI 77499XM0M87F357IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT

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 SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
ndc (package): 84090-004-01
ndc (product): 84090-004
ndc11 (package): 84090000401
spl id: 4052c4e4-2106-80c0-e063-6294a90af41d
spl set id: 4052c4e4-2105-80c0-e063-6294a90af41d

Reported adverse events (FAERS/openFDA)#

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