FDA.reportPublic FDA data

First Aid Only SunX30 Sunscreen Lotion

Manufacturer
Acme United Corporation
Effective date
2021-02-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:51:10

Label at a glance#

ProductFirst Aid Only SunX30 Sunscreen
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure9 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

apply liberally 15 minutes before sun exposure reapply: after 80 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, ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocylene 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of the eyes. Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 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 10:00 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.

Children under 6 months: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat or direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylhexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan, oleate, theobroma cacao (cocoa) seed butter, tocopherol acetate, water

Questions

OTC - QUESTIONS SECTION

1-800-835-2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton image carton imagecarton image

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-08010924-0801-01
65753-106

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYSORBATE 207T1F30V5YHIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
PROPYLENE GLYCOL PROPYL ETHER92KA3PYX0SIACT
MEDIUM DENSITY POLYETHYLENE3W404QE89SIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
24b07e10-4a06-db05-e063-6394a90a27e8bba485f9-97f8-87ee-e053-2a95a90ac0772024-10-17WarningsExact identifier
spl set id: bba485f9-97f8-87ee-e053-2a95a90ac077

Reported adverse events (FAERS/openFDA)#

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