Label: SKINDOG- avobenzone,octocrylene,oxybenzone,homosalate,octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 42657-111-01 - Packager: SkinDog, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 5, 2012
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PRINCIPAL DISPLAY PANEL
Active Ingredients: Purpose
Avobenzone 3.0%...................................................................................................Sunscreen (A)
Octocrylene 4.0%...................................................................................................Sunscreen (B)
Oxybenzone 6.0%...................................................................................................Suncreeen (A)
Homosalate 15.0%.................................................................................................Sunscreen (B)
Octisalate 5.0%...................................................................................................Sunscreen (B)
- Uses
- Warnings
- Directions
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Inactive Ingredients
Aqua; Acrylates/C10-30 Alkyl Acrylate Crosspolymer; Sorbitol; Marshmellow Extract,; Ivy Extract; Cucumber Extract; Elder Flower; Arnica Extract; EDTA; Aloe Barbadensis Leaf Juice; Isopropyl Palmitate; Stearic Acid; PEG100 Stearate; Dimethicone; Cetyl Alcohol; Glyceryl Stearate; C12-15 Alkyl Benzoate; Cetearyl Alcohol, Ceteareth-20; Phenoxyethanol Ethylhexyl Glycerin; Triethanolamine; Tetrasodium EDTA; Tocopheryl Acetate
- PRINCIPAL DISPLAY PANEL
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- KEEP OUT OF REACH OF CHILDREN
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INGREDIENTS AND APPEARANCE
SKINDOG
avobenzone,octocrylene,oxybenzone,homosalate,octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42657-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 1.70 g in 56.7 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 8.5 g in 56.7 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 3.4 g in 56.7 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 2.8 g in 56.7 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.27 g in 56.7 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Isopropyl Palmitate (UNII: 8CRQ2TH63M) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) GLYCERYL DISTEARATE (UNII: 73071MW2KM) STEARIC ACID (UNII: 4ELV7Z65AP) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL ALCOHOL (UNII: 936JST6JCN) POLYOXYL 100 STEARATE (UNII: YD01N1999R) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) ALOE VERA LEAF (UNII: ZY81Z83H0X) Dimethicone (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CUCUMBER (UNII: YY7C30VXJT) HEDERA HELIX LEAF (UNII: ZP9XFG71A7) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) EDETATE SODIUM (UNII: MP1J8420LU) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42657-111-01 56.7 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/05/2012 Labeler - SkinDog, LLC (078352090)