VIBRIANCE SUNSCREEN BROAD SPECTRUM SPF 50- octinoxate, zinc oxide lotion 
Prime Enterprises

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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Vibriance SHEER ZINC SUNSCREEN BROAD SPECTRUM SPF 50

Active Ingredients

Octinoxate 7.5%

Zinc Oxide 9%

Purpose

Sunscreen

Uses:

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keeo out of the eyes.

Rinse with water to remove.

Stop use and ask a doctor if arash occurs

Kep out of reach of children if product is walloed, get medical help or contact a Poison Control Center right away

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

Inactive Ingredients

Butylene Glycol, Cyclopentasiloxane, Ethylhexyl Stearate, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isopropyl Palmitate, Niacinamide, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, PEG-7 Trimethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Other information

Questions or comments?

Distributed by Vibriance: 400 Wes Peachtree St NW STE 4-1042 ATLANTA, GA 30308

(800) 385-3245

Vibriance SHEER ZINC Sunscreen Broad Spectrum SPF 50

Principal Display Label

VIBRIANCE  SUNSCREEN BROAD SPECTRUM SPF 50
octinoxate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0297
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE80.475 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE96.57 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
TRIMETHYLOLPROPANE (UNII: 090GDF4HBD)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Product Characteristics
Colorwhite (NUDE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0297-350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/23/2019
Labeler - Prime Enterprises (101946028)
Registrant - Prime Enterprises (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028pack(58443-0297) , manufacture(58443-0297) , label(58443-0297) , analysis(58443-0297)

Revised: 5/2020
Document Id: a4991831-7dcc-c459-e053-2995a90aff91
Set id: a4993217-16d2-6fcd-e053-2a95a90a1d35
Version: 1
Effective Time: 20200501
 
Prime Enterprises