Label: ALGENIST- avobenzone, homosalate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53407-104-60 - Packager: Solazyme, Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 8, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
Apply liberally to the entire face, neck, and chest area in the morning or 15 minutes prior to sun exposure.
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor.
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.
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Inactive Ingredients
Water/Aqua/Eau, Silica, Butylene Glycol, Pentylene Glycol, Caprylic/Capric Triglyceride, Glycerin, PEG-100 Stearate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter), Di-C12-15 Alkyl Fumarate, Cetearyl Alcohol, Cetyl Phosphate, Algae Exopolysaccharides, Malus Domestica Fruit (Apple) Cell Culture Extract, Bambusa Vulgaris (Bamboo) Leaf/Stem Extract, Tetrapeptide-21, Pisum Sativum (Pea) Extract, Enantia Chlorantha Bark Extract, Alaria Esculenta Extract, Sodium Ascorbyl Phosphate, Biotin, Glucosamine HCL, Eucalyptus Globulus Leaf Oil, Ergothioneine, Oleanolic Acid, Stearic Acid, Carbomer, Xanthan Gum, Lecithin, Mannitol, Disodium EDTA, Caprylyl Glycol, Ethylhexylglycerin, Aminomethyl Propanol, Hexylene Glycol, Phenoxyethanol.
- Other Information
- Questions Call toll free 1-877-650-1837
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALGENIST
avobenzone, homosalate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53407-104 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 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Butylene Glycol (UNII: 3XUS85K0RA) Pentylene Glycol (UNII: 50C1307PZG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) glycerin (UNII: PDC6A3C0OX) Peg-100 Stearate (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SHEA BUTTER (UNII: K49155WL9Y) DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Cetyl Phosphate (UNII: VT07D6X67O) APPLE (UNII: B423VGH5S9) Tetrapeptide-21 (UNII: 179JUC43HU) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) ALARIA ESCULENTA (UNII: EJ9JK8J58D) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) Biotin (UNII: 6SO6U10H04) EUCALYPTUS OIL (UNII: 2R04ONI662) ERGOTHIONEINE (UNII: BDZ3DQM98W) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) stearic acid (UNII: 4ELV7Z65AP) ethylhexylglycerin (UNII: 147D247K3P) caprylyl glycol (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) Xanthan Gum (UNII: TTV12P4NEE) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) mannitol (UNII: 3OWL53L36A) EDETATE DISODIUM (UNII: 7FLD91C86K) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) phenoxyethanol (UNII: HIE492ZZ3T) hexylene glycol (UNII: KEH0A3F75J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53407-104-60 1 in 1 BOX 1 1 in 1 CARTON 1 60 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2012 Labeler - Solazyme, Inc. (145862012) Establishment Name Address ID/FEI Business Operations PhytogenX,Inc 010297942 MANUFACTURE(53407-104)