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

XXL Demi Make Up SPF 50 by

Drug Labeling and Warnings

XXL Demi Make Up SPF 50 by is a Otc medication manufactured, distributed, or labeled by Peer Pharma Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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.

INGREDIENTS AND APPEARANCE

XXL DEMI MAKE UP SPF 50 
octinoxate, octocrylene, octisalate, avobenzone, homosalate, titanium dioxide, cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1803-1	100 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/24/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/24/2018

Labeler - Peer Pharma Ltd. (514678390)

Registrant - Peer Pharma Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharma Ltd.		514678390	manufacture(69435-1803)