JUSTICE BY AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 PINK GLITTER SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
Prime Enterprises 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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Justice SFP 50 Pink Glitter Sunscreen Lotion

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

Purpose

Sunscreen

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.

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.

Directions

  • apply liberally 15 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 broad spectrum SPF 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: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice Powder, Aluminum, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyethylene, Polyethylene Terephthalate, Polysilicone-15, Polysorbate 20, Polyurethane-33, Propylene Glycol, Red 34, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Yellow 5

Other Information

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics or surfaces

Questions or comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Justice by Australian Gold PINK GLITTER SUNSCREEN LOTION SPF 50 Flamingo Fuit Punch

Principal Display Label

JUSTICE BY AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50 PINK GLITTER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0253
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)  
D&C RED NO. 34 (UNII: BAN556989E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
COCOA BUTTER (UNII: 512OYT1CRR)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 1.00-2.00) (UNII: KJ6GWA9DJ0)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
TEA TREE OIL (UNII: VIF565UC2G)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALLANTOIN (UNII: 344S277G0Z)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM (UNII: CPD4NFA903)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Product Characteristics
Colorwhite (Off-white with Pink shimmer) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0253-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/201701/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/07/201701/29/2018
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0253) , manufacture(58443-0253) , label(58443-0253) , analysis(58443-0253)

Revised: 5/2022
Document Id: dec219d8-f686-0dc2-e053-2a95a90a09ca
Set id: 6633c732-d6fe-b33c-e053-2a91aa0a9e05
Version: 3
Effective Time: 20220511
 
Prime Enterprises Inc.