BELLAME BROAD SPECTRUM SPF 50- homosalate, zinc oxide, octocrylene, octisalate lotion 
Prime Matter Labs West

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Active Ingredients

Homosalate 10%

Zinc Oxide 5%

Octocrylene 5%

Octisalate 5%

Purpose

Sunscreen

Uses

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.

Stp 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

acrylic acid/vp crosspolymer, adansonia digitata seed oil, aloe barbadensis leaf juice, butyloctyl salicylate, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, disodium edta, ethyl ferulate, ethylhexylglycerin, glycerin, helianthus annuus (sunflower) seed oil, olea europaea (olive) fruit oil, phenoxyethanol, pongamia pinnata seed extract, rubus idaeus (raspberry) seed oil, simmondsia chinensis (jojoba) seed oil, sodium hydroxide, tocopheryl acetate, triethoxycaprylylsilane, vp/acrylates/lauryl methacrylate copolymer, water

Other Information

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-833-235-5263

Principal Display Label

BELLAME  BROAD SPECTRUM SPF 50
homosalate, zinc oxide, octocrylene, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82956-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50.25 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50.25 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYL FERULATE (UNII: 5B8915UELW)  
SHEA BUTTER (UNII: K49155WL9Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
JOJOBA OIL (UNII: 724GKU717M)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
LAURYL METHACRYLATE (UNII: B6L83074BZ)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82956-0003-350 mL in 1 TUBE; Type 0: Not a Combination Product05/03/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/03/2024
Labeler - Prime Matter Labs West (118568102)
Registrant - Prime Matter Labs West (118568102)
Establishment
NameAddressID/FEIBusiness Operations
Prime Matter Labs West118568102label(82956-0003) , manufacture(82956-0003) , pack(82956-0003)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028analysis(82956-0003)

Revised: 5/2024
Document Id: 1790046f-0733-6094-e063-6294a90a7329
Set id: 1790046f-0732-6094-e063-6294a90a7329
Version: 1
Effective Time: 20240503
 
Prime Matter Labs West