SUN SHADES SPORT SPORT PLUS- avobenzone, homosalate, octisalate, and octocrylene spray 
Melaleuca, Inc.

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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Sun Shades Sport 45+

Active ingredients
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose
Sunscreen

Warnings
For external use only

Flammable: do not use near heat, flame, or while smoking

When using this product

Stop use and ask a doctor if rash or irritation develops and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients
acrylates/octacrylamide copolymer, aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, C12-15 alkyl benzoate, caprylic/capric triglyceride, disodium lauriminodipropionate tocopheryl phosphate, macadamia ternifolia seed oil, parfum, phenyl trimethicone, polyester-10, propylene glycol dibenzoate, SD alcohol 40-B, tocopherol

image of label
SUN SHADES  SPORT SPORT PLUS
avobenzone, homosalate, octisalate, and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-163
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.7106 g  in 177 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE23.553 g  in 177 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7.851 g  in 177 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15.702 g  in 177 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BIXA ORELLANA SEED (UNII: O87354RZ5A)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
LEVOMENOL (UNII: 24WE03BX2T)  
MACADAMIA OIL (UNII: 515610SU8C)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-163-06177 mL in 1 CAN; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2009
Labeler - Melaleuca, Inc. (139760102)
Registrant - Melaleuca, Inc. (079711683)

Revised: 1/2023
Document Id: f2077821-678a-72bc-e053-2a95a90afe26
Set id: 2952cf1e-2553-49af-894a-5297ce447172
Version: 5
Effective Time: 20230111
 
Melaleuca, Inc.