Sun Shades Sport 45+

Sun Shades Sport 45+

Drug Labeling and Warnings

Drug Details

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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

  • keep out of eyes. Rinse with water to remove.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

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

  • shake well before first use
  • apply evenly and liberally to all exposed areas before sun exposure
  • do not spray directly on face. Spray on hands to apply to face
  • use in well-ventilated area
  • reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
  • children under 6 months of age: ask a doctor

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
  • may stain some fabrics

Other information

  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

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: 3/2018
 
Melaleuca, Inc.


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