XXL SUN BLOCK 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 Sun Block SPF 25

sun block

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: Apply generously to face and body regularly before sun exposure and as needed.

Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.

Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

XXL SUN BLOCK SPF 50 
octinoxate, octocrylene, octisalate, avobenzone, homosalate, titanium dioxide cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1804
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 mL
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
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL (UNII: 724GKU717M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALMOND OIL (UNII: 66YXD4DKO9)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALLANTOIN (UNII: 344S277G0Z)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
SHEA BUTTER (UNII: K49155WL9Y)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SEA SALT (UNII: 87GE52P74G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
WATER (UNII: 059QF0KO0R)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1804-1100 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(69435-1804)

Revised: 5/2018
Document Id: 6cf6cd4b-7be8-6bad-e053-2991aa0a2020
Set id: 6cf6cd4b-7be7-6bad-e053-2991aa0a2020
Version: 1
Effective Time: 20180524
 
Peer Pharma Ltd.