Label: OIL FREE MATTE SPF 30- avobenzone, homosalate, octisalate, and oxybenzone lotion
- NDC Code(s): 68479-110-02
- Packager: Dermalogica
- 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 December 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
-
Inactive Ingredients
Water/Aqua/Eau, Butylene Glycol, PPG-3 Benzyl Ether Ethylhexanoate, Nylon-12, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Stearic Acid, Polysorbate 80, Leuconostoc/Radish Root Ferment Filtrate, Carthamus Tinctorius (Safflower) Oleosomes, Camellia Sinensis Leaf Extract, Citrus Grandis (Grapefruit) Fruit Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Ammonium Glycyrrhizate, Enantia Chlorantha Bark Extract, Panthenol, Zinc Gluconate, Caffeine, Biotin, Oleanolic Acid, Tocopheryl Acetate, Yeast Extract, Niacinamide, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Behenyl Alcohol, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Sorbitan Stearate, Cetyl Alcohol, Glyceryl Stearate SE, Gluconic Acid, Propylene Glycol, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Sodium Hydroxide.
- Other information
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
OIL FREE MATTE SPF 30
avobenzone, homosalate, octisalate, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 80 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 40 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) PPG-3 Benzyl Ether Ethylhexanoate (UNII: 3N703GY99W) Butylene Glycol (UNII: 3XUS85K0RA) Nylon-12 (UNII: 446U8J075B) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458) Stearic Acid (UNII: 4ELV7Z65AP) Polysorbate 80 (UNII: 6OZP39ZG8H) Annickia Chlorantha Bark (UNII: H70115MP4A) Oleanolic Acid (UNII: 6SMK8R7TGJ) Niacinamide (UNII: 25X51I8RD4) Yeast, Unspecified (UNII: 3NY3SM6B8U) Horse Chestnut (UNII: 3C18L6RJAZ) Ammonium Glycyrrhizate (UNII: 3VRD35U26C) Panthenol (UNII: WV9CM0O67Z) Zinc Gluconate (UNII: U6WSN5SQ1Z) Gluconic Acid (UNII: R4R8J0Q44B) Propylene Glycol (UNII: 6DC9Q167V3) Caffeine (UNII: 3G6A5W338E) Biotin (UNII: 6SO6U10H04) Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Cetyl Alcohol (UNII: 936JST6JCN) Glyceryl Stearate SE (UNII: FCZ5MH785I) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) Sorbitan Monostearate (UNII: NVZ4I0H58X) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) Isohexadecane (UNII: 918X1OUF1E) PUMMELO (UNII: ET1TN5W71X) Polysorbate 60 (UNII: CAL22UVI4M) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Xanthan Gum (UNII: TTV12P4NEE) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Hydroxide (UNII: 55X04QC32I) Edetate Disodium (UNII: 7FLD91C86K) Docosanol (UNII: 9G1OE216XY) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-110-02 1 in 1 CARTON 02/16/2012 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 02/16/2012 Labeler - Dermalogica (177698560) Establishment Name Address ID/FEI Business Operations Cosway 052400223 MANUFACTURE(68479-110)
