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

Sun Shades by

Drug Labeling and Warnings

Sun Shades by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose
Sunscreen

WARNINGS

Warnings
For external use only

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

WHEN USING

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

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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
  

GENERAL PRECAUTIONS

• 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
  

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN SHADES  SPORT SPORT PLUS
avobenzone, homosalate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	4.7106 g  in 177 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	23.553 g  in 177 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7.851 g  in 177 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15.702 g  in 177 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-163-06	177 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2009

Labeler - Melaleuca, Inc. (139760102)

Registrant - Melaleuca, Inc. (079711683)