País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
ARAMIS INC
TOPICAL
OTC DRUG
OTC monograph not final
ARAMIS LAB SERIES POWER PROTECTOR SPF 50- OCTISALATE, HOMOSALATE, AVOBENZONE, OXYBENZONE LOTION ARAMIS INC _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._ ---------- ACTIVE INGREDIENTS: OCTISALATE 5.00% [] HOMOSALATE 5.00% [] AVOBENZONE 3.00% [] OXYBENZONE 3.00% WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN. PRINCIPAL DISPLAY PANEL: ARAMIS LAB SERIES POWER PROTECTOR SPF 50 SKIN CARE FOR MEN 3.4 FL OZ/ 100 ML ARAMIS INC. NEW YORK, NY 10022 ARAMIS LAB SERIES POWER PROTECTOR SPF 50 octisalate, homosalate, avobenzone, oxybenzone lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:42472-720 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W) OCTISALATE 5.0 mL in 10 0 mL HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S) HOMOSALATE 5.0 0 mL in 10 0 mL AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX) AVOBENZONE 3.0 0 in 10 0 mL O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y) OXYBENZONE 3.0 0 mL in 10 0 mL PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:42472-720 -0 1 1 in 1 CARTON 1 NDC:42472-720 -0 2 10 0 mL in 1 TUBE MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt352 12/0 1/20 0 9 LABELER - ARAMIS INC (042918826) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS ESTEE LAUDER COSMETICS, LTD 20 59 5238 5 ma nufa c ture ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS ESTEE LAUDER N.V. 370 151326 ma nufa c ture ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Len-Ro n Manufacturing Divisio n o f Aramis Inc. 8 0 9 771152 ma nufa c ture E Llegiu el document complet