![XXL DEMI MAKE UP SPF 50 (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE, CREAM) CREAM [PEER PHARMA LTD.]](https://medic.hrt.org//dailymed/images/6cf544a1-52ae-962a-e053-2a91aa0ab67f/demi make up.jpg)
| NDC | 69435-1803-1 |
| Set ID | 6cf544a1-52ae-962a-e053-2a91aa0ab67f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Peer Pharma Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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PRINCIPAL DISPLAY PANEL
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.
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INGREDIENTS AND APPEARANCE
XXL DEMI MAKE UP SPF 50
octinoxate, octocrylene, octisalate, avobenzone, homosalate, titanium dioxide, cream creamProduct 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)