FIRST AID ONLY SUNX30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

First Aid Only SunX30 Sunscreen by

Drug Labeling and Warnings

First Aid Only SunX30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocylene 5%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of the eyes. Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of the reach of children.

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

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.

Directions

• 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

• Protect this product from excessive heat or direct sun.

Inactive ingredients

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

1-800-835-2263

PRINCIPAL DISPLAY PANEL

carton image

INGREDIENTS AND APPEARANCE

FIRST AID ONLY SUNX30 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0801(NDC:65753-106)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S)
MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0801-01	4 in 1 CARTON	02/22/2021
1		7 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/22/2021

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0801) , repack(0924-0801)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-0801) , repack(0924-0801)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		117825595	relabel(0924-0801) , repack(0924-0801)