ACADEMY SPF 50  - avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
ACADEMY, LTD

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.

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Drug Facts

Active Ingredients

AVOBENZONE 1.5%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 1.2%, 

OXYBENZONE 6.0%

Purpose

Sunscreen

Uses


Warning

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

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

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


NDC 59054-880-10

Academy

SPORTS+OUTDOOR

SUNSCREEN LOTION

BROAD SPECTRUM

SPF 50

40

Water Resistant

(80 Minutes)

Hypoallergenic

UVA/UVB protection

16 FL. OZ.

(473 mL)

Label



ACADEMY SPF 50  
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59054-880
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59054-880-10473 g in 1 BOTTLE; Type 0: Not a Combination Product07/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/20/2016
Labeler - ACADEMY, LTD (065092538)

Revised: 7/2016
Document Id: 42836d50-8548-4c84-be25-96b01416d489
Set id: f9ed373e-1ce0-4765-acb3-90f6e012a902
Version: 1
Effective Time: 20160720
 
ACADEMY, LTD