NDC | 70897-008-01 |
Set ID | 803bf1cc-331b-2ce7-e053-2a91aa0a1d53 |
Category | HUMAN OTC DRUG LABEL |
Packager | Davemed Healthcare Co., Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Other Information
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SUNSCREEN CREAM SPF 30
homosalate, octyl methoxycinnamate, benzophenone-3, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70897-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERIN (UNII: PDC6A3C0OX) EDETIC ACID (UNII: 9G34HU7RV0) VINYL CHLORIDE (UNII: WD06X94M2D) GLATIRAMER ACETATE (UNII: 5M691HL4BO) DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70897-008-01 6 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2019 Labeler - Davemed Healthcare Co., Ltd (529128716) Establishment Name Address ID/FEI Business Operations Davemed Healthcare Co., Ltd 529128716 manufacture(70897-008)