Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Private Label Select Ltd CO
TOPICAL
OTC DRUG
OTC monograph final
SUNSCREEN- ZINC OXIDE SUNSCREEN STICK PRIVATE LABEL SELECT LTD CO _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._ ---------- THINK OPERATIONS, THINK BABY SPF 30 STICK CANADIAN OTC - KEEP OUT OF REACH OF CHILDREN OTC - ACTIVE INGREDIENTS DOS AGE INACTIVE INGREDIENTS INDICATIONS AND USAGE PURPOSE SECTION WARNINGS FRONT LABEL BACK LABEL UNIT CARTON PART 1 UNIT CARTON PART 2 SUNSCREEN zinc oxide sunscreen stick PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 29 32-212 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH Private Label Select Ltd CO CO CO NUT O IL (UNII: Q9 L0 O73W7L) SUNFLO WER O IL (UNII: 3W1JG79 5YI) .BETA.-TO CO PHERO L (UNII: 9 U6 A49 0 50 1) CANDELILLA WAX (UNII: WL0 328 HX19 ) SHEA BUTTER (UNII: K49 155WL9 Y) CASTO R O IL (UNII: D5340 Y2I9 G) WHITE WAX (UNII: 7G1J5DA9 7F) CARNAUBA WAX (UNII: R12CBM0 EIZ) CO CO A BUTTER (UNII: 512OYT1CRR) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) PRODUCT CHARACTERISTICS COLOR white S CORE S HAP E S IZ E FLAVOR FRUIT (Papaya Lychee) IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:6 29 32-212- 19 1 in 1 CARTON 0 5/0 1/20 19 1 18 .4 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa rt352 0 5/0 1/20 19 LABELER - Private Label Select Ltd CO (005415463) Revised: 12/2019 Lesen Sie das vollständige Dokument