Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
OCTISALATE 7.3%, OXYBENZONE 4.7%
Nemadji Management LLC
TOPICAL
OTC DRUG
SUNSCREEN PREVENTS SUNBURN
OTC monograph not final
HEMP LIP BALM- OCTISALATE, OXYBENZONE LIPSTICK NEMADJI MANAGEMENT LLC _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 7.3% OXYBENZONE 4.7% PURPOSE SUNSCREEN WARNINGS EXTERNAL USE ONLY KEEP OUT OF REACH OF CHILDREN. USES PREVENTS SUNBURN DIRECTIONS APPLY TO AFFECTED AREA AS DESIRED. INACTIVE INGREDIENTS Hemp flower oil, Coconut oil, Beeswax, Patrolatum, Candelilla wax, Dimethicone, Aloe oil, Flavor, Tocopherol Acetate. HEMP LIP BALM octisalate, oxybenzone lipstick PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:73278 -20 1 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 7.3 g in 10 0 mL O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y) OXYBENZONE 0 .4 g in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CANNABIS SATIVA SUBSP. SATIVA FLO WERING TO P (UNII: 8 X454SZ22D) Nemadji Management LLC CO CO NUT O IL (UNII: Q9 L0 O73W7L) YELLO W WAX (UNII: 2ZA36 H0 S2V) PETRO LATUM (UNII: 4T6 H12BN9 U) CANDELILLA WAX (UNII: WL0 328 HX19 ) DIMETHICO NE (UNII: 9 2RU3N3Y1O) ALO E VERA WHO LE (UNII: KIZ4X2EHYX) .ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 ) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:73278 -20 1-11 10 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 8 /0 7/20 19 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 0 8 /0 7/20 19 LABELER - Nemadji Management LLC (100279564) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS DIVERSIFIED MANUFACTURING CORP 18 50 739 9 6 ma nufa c ture (73278 -20 1) Revised: 8/2019 Læs hele dokumentet