Country: United States
Language: English
Source: NLM (National Library of Medicine)
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Nature&Bio Co., Ltd.
Zinc Oxide
ZINC CATION 2.14 g in 12 g
OTC DRUG
OTC monograph not final
UV NATURAL 100 MINERAL SUNKILL RX 12G- ZINC OXIDE , TITANIUM DIOXIDE POWDER NATURE&BIO CO., 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._ ---------- ACTIVE INGREDIENT Active ingredients: Zinc Oxide 17.9%, Titanium Dioxide 17.3% INACTIVE INGREDIENT Inactive ingredients: Mica, Silica, Bismuth Oxychloride, CI 77492, CI 77491, CI 77499, Quartz, Sapphire Powder PURPOSE Purpose: Sunscreen WARNINGS Warnings: For external use only. When using this product Keep out of eyes, Rinse with water to remove. Stop use and ask a doctor if Rash or irritation develops and lasts, Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN INDICATIONS & USAGE Indications and usage: Helps prevent sunburn, Higher SPF gives moresunburn protection. DOSAGE & ADMINISTRATION Dosage and administration: Apply evenly before sun exposure as needed. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL UV NATURAL 100 MINERAL SUNKILL RX 12G zinc oxide , titanium dioxide powder PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 0 58 -0 40 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37) ZINC CATION 2.14 g in 12 g TITA NIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP) Titanium Dio xide 2.0 7 g in 12 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH MICA (UNII: V8 A1AW0 8 8 0 ) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE Nature&Bio Co., Ltd. 1 NDC:6 9 0 58 -0 40 -0 1 12 g in 1 CARTON 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 14 LABELER - Nature&Bio Co., Ltd. Read the complete document