SUNSHINE AND GLITTER BROAD SPECTRUM SPF 50 RAINBOW GLITTER SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene 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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Sunshine & Glitter Sea Star Sparkle Rainbow Glitter Sunscreen Lotion Broad Spectrum SPF 50

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

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 40 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 Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aluminum, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Phenoxyethanol, Polybutylene Terephthalate, Polyethylene , Polylactic Acid, Polysorbate 20, Polyurethane, Polyurethane-33, Propylene Glycol, Red 7, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Water (Aqua), Yellow 6

Questions or comments?

Call 1-888-601-0441

Sunshine & Glitter Sea Star Sparkle Rainbow Glitter Sunscreen Lotion Broad Spectrum SPF 50

Principle Display Label

SUNSHINE AND GLITTER  BROAD SPECTRUM SPF 50 RAINBOW GLITTER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0521
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE51 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE101 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYURETHANE-34 (55 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: II1242QJ7P)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
COCOA BUTTER (UNII: 512OYT1CRR)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM (UNII: CPD4NFA903)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYLACTIDE (UNII: 459TN2L5F5)  
POLYURETHANE-62 (UNII: TBK645J3J8)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colorwhite (White with Colored Speckles) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0521-3100 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/15/2021
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0521) , manufacture(58443-0521) , label(58443-0521) , analysis(58443-0521)

Revised: 1/2022
Document Id: d5cea478-27fa-6815-e053-2995a90a9f7b
Set id: d5ce9d25-becf-0dde-e053-2995a90ac4f9
Version: 1
Effective Time: 20220117
 
Prime Enterprises Inc.