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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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First Aid Only SunX30 Sunscreen Lotion

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

Directions

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:

Children under 6 months: Ask a doctor

Other information

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 carton image

FIRST AID ONLY SUNX30 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0801(NDC:65753-106)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-0801-014 in 1 CARTON02/22/2021
17 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/22/2021
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-0801) , repack(0924-0801)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-0801) , repack(0924-0801)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation117825595relabel(0924-0801) , repack(0924-0801)

Revised: 2/2021
Document Id: bba48cd2-9c2c-5623-e053-2995a90ad3d6
Set id: bba485f9-97f8-87ee-e053-2a95a90ac077
Version: 1
Effective Time: 20210218
 
Acme United Corporation