FDA.reportPublic FDA data

Roe Wellness SPF 30 Mineral Sunscreen

Manufacturer
Smalls Brand LLC DBA Roe Wellness
Effective date
2026-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:33

Label at a glance#

ProductSPF 30 Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide 19.0%

Purpose: Sunscreen

OTC - PURPOSE SECTION

Uses:

Helps prevent sunburn. Higher SPF gives more sunburn protection.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

WARNINGS SECTION

Warning:

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.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally 5 minutes before sun or water exposure
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Ethylhexyl Olivate, Dimethicone, C9-12 Alkane, Cocoglycerides, Hydroxyethyl Dimethicone Laurate, Pentylene Glycol, Butyloctyl Salicylate, Glycerin, Jojoba Esters, Pyrus Malus (Apple) Fruit Extract, Polymethylsilsesquioxane, Squalane, Dipotassium glycyrrhizate, Beta Vulgaris (Beet) Root Extract. Fructooligosaccharides. Glycine Soja (Soybean) Seed Extract Diheptyl Succinate, Disteardimonium Hectorite, Phenoxyethanol, Sodium Chloride, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Hydroxyacetophenone, Sodium Citrate, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Capryloyl Glycerin/Sebacic Acid Copolymer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 30 Mineral Sunscreen

Net Wt 1.76 oz 50 g

SPF 30 cartonSPF 30 carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83369-003-01SPF 30 Mineral Sunscreen50 g in 1 CARTONCREAM501

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
83369-00383369-003-01

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
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM CHLORIDE451W47IQ8XIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
C9-12 ALKANE7J5R5W72QMIACT
PENTYLENE GLYCOL50C1307PZGIACT
GLYCERINPDC6A3C0OXIACT
APPLEB423VGH5S9IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SQUALANEGW89575KF9IACT
ETHYLHEXYL OLIVATEHTC7G3S2PVIACT
COCOGLYCERIDESISE9I7DNUGIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
DIMETHICONE92RU3N3Y1OIACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
SODIUM CITRATE1Q73Q2JULRIACT
BEETN487KM8COKIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDESN2UDM48ZD6IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ZINC OXIDESOI2LOH54ZACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
WATER059QF0KO0RIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
SOYBEANL7HT8F1ZODIACT

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
SPF 30 Mineral SunscreenZINC OXIDESmalls Brand LLC DBA Roe Wellness4c25b4ec-b045-7066-e063-6294a90ab8012026-03-03WarningsExact identifier
ndc (package): 83369-003-01
ndc (product): 83369-003
ndc11 (package): 83369000301
spl id: 4c25b4ec-b046-7066-e063-6294a90ab801
spl set id: 4c25b4ec-b045-7066-e063-6294a90ab801

Reported adverse events (FAERS/openFDA)#

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