Label: ACADEMY SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 59054-880-10
- Packager: ACADEMY, LTD
- 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 July 20, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warning
For external use only
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
- May stain some fabrics.
Directions
- apply liberally15 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 .am. to 2 p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
- children under 6 months of age: Ask a doctor
- May stain some fabrics.
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Inactive Ingredients
Water, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Stearyl Alcohol, Glycerin, Caprylyl Glycol, Cetyl Alcohol, Triethanolamine, Carbomer, Glyceryl Stearate, Behenyl Alcohol, Xanthan Gum, Sodium Lauroyl Sarcosinate, Disodium EDTA, Dipropylene Glycol, BHT, Disodium Ethylene Dicocamide PEG-15 Disulfate, Glyceryl Stearate Citrate, Cetearyl Alcohol, Sodium Lauroyl Lactylate, Retinyl Palmitate, Tocopheryl Acetate, Lecithin, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Methyldibromo Glutaronitrile, Methylchloroisothiazolinone, Methylisothiazolinone.
- Other information
- Principle Display Label
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INGREDIENTS AND APPEARANCE
ACADEMY SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59054-880 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.2 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) EDETATE DISODIUM (UNII: 7FLD91C86K) DIPROPYLENE GLYCOL (UNII: E107L85C40) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59054-880-10 473 g in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/20/2016 Labeler - ACADEMY, LTD (065092538)