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

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First Aid Only SunX30 Sunscreen Lotion

Active ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocylene 5%

Purpose

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

carton image

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/22/2021	07/03/2023

Labeler - Acme United Corporation (001180207)

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

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

Revised: 10/2024

Document Id: 24b07e10-4a06-db05-e063-6394a90a27e8

Set id: bba485f9-97f8-87ee-e053-2a95a90ac077

Version: 2

Effective Time: 20241017

Acme United Corporation