FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30

Manufacturer
Port Jervis Laboratories, Inc.
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:58

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

shake well before use apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating 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 or higher and other sun protection measures including: limit time in ...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 22%

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use water resistant sunscreen if swimming or sweating
  • 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 or higher and other sun protection measures including:
    • limit time in sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethylhexyl olivate, isododecane, coconut alkanes, water, aluminum starch octenylsuccinate, caprylic/capric triglyceride, butylene glycol, mica, polyglyceryl-6 polyricinoleate, jojoba esters, cellulose, stearalkonium hectorite, sodium chloride, squalane, polyglyceryl-3 diisostearate, polyglyceryl-3 polyricinoleate, iron oxides, phenoxyethanol, tocopheryl acetate, coco-caprylate/caprate, trihydroxystearin, caprylyl glycol, polyhydroxystearic acid, glycerin, trisodium ethylenediamine disuccinate, propanediol, sorbic acid, titanium dioxide, silica, glycyrrhiza glabra (licorice) root extract, camellia sinensis leaf extract, alumina, tocopherol, chrysanthemum parthenium (feverfew) extract

Questions?

OTC - QUESTIONS SECTION

888-FAB-3063

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIRST AID BEAUTY ​®

FAB

Ultra Light

Mineral

Sunscreen

with Zinc Oxide

Broad Spectrum SPF 30

1.5 FL OZ (44 mL) ulm labelulm label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10637-1900-1First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 3044 mL in 1 BOTTLE, PLASTICLIQUID441
10637-1900-1First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 301 in 1 CARTONLIQUID11

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10637-190010637-1900-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYL OLIVATEHTC7G3S2PVIACT
FERROUS OXIDEG7036X8B5HIACT
POWDERED CELLULOSESMD1X3XO9MIACT
TANACETUM PARTHENIUM WHOLE6GE7Z0761KIACT
POLYGLYCERYL-10 POLYRICINOLEATEDHM1T5XO11IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT2788Z9758HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALUMINALMI26O6933IACT
MICAV8A1AW0880IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
COCONUT ALKANES1E5KJY107TIACT
ISODODECANEA8289P68Y2IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
SILICAETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SQUALANEGW89575KF9IACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
PROPANEDIOL5965N8W85TIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBIC ACIDX045WJ989BIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ZINC OXIDESOI2LOH54ZACTIB

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
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEPort Jervis Laboratories, Inc.4b442fdf-a9cf-7e5a-e063-6394a90a9e1e2025-07-01WarningsExact identifier
ndc (package): 10637-1900-1
ndc (product): 10637-1900
ndc11 (package): 10637190001
spl id: 4b44294f-5ab3-7d68-e063-6394a90ac45f
spl set id: 4b442fdf-a9cf-7e5a-e063-6394a90a9e1e

Reported adverse events (FAERS/openFDA)#

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