Country: United States
Language: English
Source: NLM (National Library of Medicine)
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
Peer Pharm Ltd.
TOPICAL
OTC DRUG
OTC monograph final
SPA PHARMA MULTI VITAMIN CREAM SPF 25- OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE CREAM PEER PHARM 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._ ---------- SPA PHARMA MULTI VITAMIN CREAM SPF 25 SPA PHARMA MULTI VITAMIN CREAM SPF 25 octinoxate, octocrylene, octisalate, avobenzone, homosalate cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 435-16 0 7 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM) OCTOCRYLENE 5 g in 10 0 mL O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W) OCTISALATE 5 g in 10 0 mL AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX) AVOBENZONE 3 g in 10 0 mL HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S) HOMOSALATE 2 g in 10 0 mL O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S) CETEARYL GLUCO SIDE (UNII: 0 9 FUA47KNA) CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R) ISO HEXADECANE (UNII: 9 18 X1OUF1E) GLYCERIN (UNII: PDC6 A3C0 OX) SIMMO NDSIA CHINENSIS SEED (UNII: D24K2Q1F6 H) SHEA BUTTER (UNII: K49 155WL9 Y) PO TASSIUM CETYL PHO SPHATE (UNII: 0 3KCY6 P7UT) NIACINAMIDE (UNII: 25X51I8 RD4) DIMETHICO NE (UNII: 9 2RU3N3Y1O) SEA SALT (UNII: 8 7GE52P74G) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC) .ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 ) PANTHENO L (UNII: WV9 CM0 O6 7Z) CHAMO MILE FLO WER O IL (UNII: 6 0 F8 0 Z6 1A9 ) PO MEGRANATE SEED O IL (UNII: 0 UI45XV0 T6 ) CAMELINA SATIVA WHO LE (UNII: W42JFE4HON) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:6 9 435-16 0 7- Read the complete document