Label: MINERALIUM HDRA SOURCE MOISTURIZING PROTECTOR SPF 25- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69435-1606-1 - Packager: Peer Pharm Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 25, 2016
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INGREDIENTS AND APPEARANCE
MINERALIUM HDRA SOURCE MOISTURIZING PROTECTOR SPF 25
octinoxate, octocrylene, octisalate, avobenzone, homosalate cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1606 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 OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISOHEXADECANE (UNII: 918X1OUF1E) GLYCERIN (UNII: PDC6A3C0OX) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) 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) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) CAMELINA SATIVA WHOLE (UNII: W42JFE4HON) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69435-1606-1 50 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/24/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/24/2016 Labeler - Peer Pharm Ltd. (514678390) Registrant - Peer Pharm Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharm Ltd. 514678390 manufacture(69435-1606)
