NDC | 15828-737-01 |
Set ID | 6d74028a-550d-4ddd-a7ff-9f7cf96162e8 |
Category | HUMAN OTC DRUG LABEL |
Packager | Zermat Internacional S.A. de C.V. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active Ingredients:
- Uses:
- Warnings:
-
Directions:
- Apply liberally 15-minutes before sun exposure. Reapply:
- At least, every two-hours.
- Immediately after swimming, sweating or towel drying.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
- Limit time in the sun, especially between 10am and 2pm.
- Wear long sleeve shirts, pants, hats and sunglasses.
- For children under 6 months, consult a physician.
-
Inactive Ingredients:
Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamidopropyl Betaine, Cucumis Sativus
(Cucumber) Fruit Extract, Cyclotetrasiloxane, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Mangifera Indica (Mango) Seed Butter, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Soluble Collagen, Sorbitan
Olivate, Tocopheryl Acetate (Vitamin E), Zemea Propanediol. - Package Labeling:
-
INGREDIENTS AND APPEARANCE
ZERMAT SKIN SPF 50 BROAD SPECTRUM
avobenzone, homosalate, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15828-737 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) SHEA BUTTER (UNII: K49155WL9Y) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL OLIVATE (UNII: 58B69Q84JO) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CUCUMBER (UNII: YY7C30VXJT) CYCLOMETHICONE 4 (UNII: CZ227117JE) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) SUNFLOWER OIL (UNII: 3W1JG795YI) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAURETH-7 (UNII: Z95S6G8201) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) SORBITAN OLIVATE (UNII: MDL271E3GR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15828-737-01 1 in 1 BOX 04/15/2016 1 48 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/15/2016 Labeler - Zermat Internacional S.A. de C.V. (812820712)