Label: XXL DEMI MAKE UP SPF 50- octinoxate, octocrylene, octisalate, avobenzone, homosalate, titanium dioxide, cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69435-1803-1 - Packager: Peer Pharma Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 24, 2018
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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)