SUN SHADES SUNSCREEN SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene spray

Sun Shades Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Purpose

Sunscreen

Uses

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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

Do not use on damaged or broken skin

Do not use on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.
• keep away from face to avoid breathing it
• do not puncture or incinerate. Contents under pressure.

Stop use and ask a doctor if rash occurs

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 using
• spray liberally and spread evenly by hand 15 minutes before sun exposure
• hold container 4 to 6 inches from skin to apply
• do not spray directly into face. Spray on hands, then apply to face.
• do not apply in windy conditions
• use a well-ventilated area
• 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

• may stain some fabrics
• protect this product from excessive heat and direct sun
• do not store at temperatures below 32 F (0 C) or above 120 F (49 C)

INACTIVE INGREDIENT

acrylates/octylacrylamide copolymer, alcohol denat, aloe barbadensis leaf juice, butylene glycol, diisopropyl adipate, fragrance (parfum), neopentyl glycol diheptanoate, simmondsia chinensis (jojoba) extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN SHADES SUNSCREEN  SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-404
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	13.04 g  in 163 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	8.15 g  in 163 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	4.89 g  in 163 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	24.45 g  in 163 mL

Inactive Ingredients
Ingredient Name	Strength
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)
SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)
PARFUMIDINE (UNII: A2Q2LHC6MA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-404-01	163 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2020

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (079711683)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca Inc		079711683	manufacture(54473-404)