XXL DEMI MAKE UP SPF 50- octinoxate, octocrylene, octisalate, avobenzone, homosalate, titanium dioxide, cream cream 
Peer Pharma Ltd.

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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Gold Cosmetics XXL Demi Make Up SPF 50

demi make up

Octinoxate 7%

Octocrylene 5%

Octisalate 5%

Avobenzone 3%

Homosalate 2%

Titanium Dioxide 3%

Keep out of reach of children.

Provides SPF 50 protection

Directions for use: gently apply "gold" demi makeup to face and neck prior to sun exposure for instant coverage and correction as well as for protection. Reapply as needed. ​

Directions for use: gently apply "gold" demi makeup to face and neck prior to sun exposure for instant coverage and correction as well as for protection. Reapply as needed.

XXL DEMI MAKE UP SPF 50 
octinoxate, octocrylene, octisalate, avobenzone, homosalate, titanium dioxide, cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1803
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
NYLON-12 (UNII: 446U8J075B)  
ALLANTOIN (UNII: 344S277G0Z)  
DOCOSANOL (UNII: 9G1OE216XY)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYGLYCERIN-10 (UNII: P9060O936A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1803-1100 mL in 1 CONTAINER; Type 0: Not a Combination Product05/24/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/24/2018
Labeler - Peer Pharma Ltd. (514678390)
Registrant - Peer Pharma Ltd. (514678390)
Establishment
NameAddressID/FEIBusiness Operations
Peer Pharma Ltd.514678390manufacture(69435-1803)

Revised: 5/2018
Document Id: 6cf544a1-52b0-962a-e053-2a91aa0ab67f
Set id: 6cf544a1-52ae-962a-e053-2a91aa0ab67f
Version: 1
Effective Time: 20180524
 
Peer Pharma Ltd.