Label: CARDON- avobenzone, homosalate, octyl salicylate lotion
- NDC Code(s): 72475-001-35
- Packager: Cardon, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 11, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- For Sunscreen Use: apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 months; Ask a doctor
- STORAGE AND HANDLING
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients water, propanediol, butyloctyl salicylate, ethylhexyl methoxycrylene, polymethyl methacrylate, butylene glycol, 1,2-hexanediol, styrene/acrylates copolymer, phenoxyethanol, fragrance, glycerin, pentylene glycol, saccharide hydrolysate, sodium acrylate/sodiumacryloyldimethyl taurate copolymer, carbomer, polyacrylate crosspolymer-6, behenyl alcohol, ethylhexyglycerin, hydroxyethyl acrylate/sodiumacryloyldimethyl taurate copolymer, tromethamine, xanthan gum, isohexadecane, curcuma longa (turmeric) root extract, portulaca oleracea extract, centella asiatica extract, houttuynia cordata extract, salvia hispanica seed extract, opuntia ficus-indica stem extract, t-butyl alcohol, disodium edta, oxygen
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CARDON
avobenzone, homosalate, octyl salicylate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72475-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.3 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) TROMETHAMINE (UNII: 023C2WHX2V) ISOHEXADECANE (UNII: 918X1OUF1E) HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) DOCOSANOL (UNII: 9G1OE216XY) XANTHAN GUM (UNII: TTV12P4NEE) TURMERIC (UNII: 856YO1Z64F) PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2) CENTELLA ASIATICA (UNII: 7M867G6T1U) SALVIA HISPANICA SEED (UNII: NU0OLX06F8) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) PHENOXYETHANOL (UNII: HIE492ZZ3T) PENTYLENE GLYCOL (UNII: 50C1307PZG) INVERT SUGAR (UNII: ED959S6ACY) EDETATE DISODIUM (UNII: 7FLD91C86K) OXYGEN (UNII: S88TT14065) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72475-001-35 35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/09/2018 Labeler - Cardon, Inc (081099910)