Country: United States
Language: English
Source: NLM (National Library of Medicine)
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)
BOBBI BROWN PROFESSIONAL COSMETICS INC
TOPICAL
OTC DRUG
OTC monograph not final
BOBBI BROWN EXTRA SPF 25 MOISTURIZING BALM- HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE CREAM BOBBI BROWN PROFESSIONAL COSMETICS 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: HOMOSALATE 10.00% [] OCTINOXATE 7.50% [] OXYBENZONE 5.00% [] AVOBENZONE 2.00% WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. DIRECTIONS: WARM IN HANDS AND APPLY TO CLEAN SKIN PRINCIPAL DISPLAY PANEL: BOBBI BROWN EXTRA SPF 25 MOISTURIZING BALM POIDS NET. 1.7 OZ / 50 ML BOBBI BROWN PROFESSIONAL COSMETICS NEW YORK, NY 10022 E109 WWW.BOBBIBROWN.COM BOBBI BROWN EXTRA SPF 25 MOISTURIZING BALM homosalate, octinoxate, oxybenzone, avobenzone cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 4141-9 16 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S) HOMOSALATE 10 mL in 10 0 mL O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 10 0 mL O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y) OXYBENZONE 5.0 mL in 10 0 mL AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX) AVOBENZONE 2.0 mL in 10 0 mL PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:6 4141-9 16 -0 1 1 in 1 CARTON 1 NDC:6 4141-9 16 -0 2 50 mL in 1 JAR 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 10 /0 1/20 0 0 LABELER - BOBBI BROWN PROFESSIONAL COSMET ICS INC (627131279) 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 Read the complete document