Label: FIRST AID ONLY SUNX30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 0924-0801-01
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 65753-106
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 18, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Warnings
- Uses
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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
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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
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY SUNX30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct 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)