NDC | 43219-005-50 |
Set ID | ba131c45-8295-44c5-b780-f6c88944d4a7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Emilia Cosmetics Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
•apply liberally 15 minutes before sun exposure •reapply at least every
2 hours •use water resistant sunscreen if swimming or sweating •children
under 6 months of age: ask a doctor.
• Sun Protection Measures: Spending time in the sun increases your
risk of skin cancer and early skin aging. To decrease this risk, regularly
use a sunscreen with a Broad Spectrum SPF value of 15 or higher and
other sun prtection measures including:
•limit time in the sun, especially from 10 am. - 2 p.m.
•wear long-sleeved shirts, pants, hats and sunglasses
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VISAGE ENVY INVISIBLE FACE GEL SPF50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43219-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.54 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.51 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.02 g in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.01 g in 50 mL Inactive Ingredients Ingredient Name Strength ISOHEXADECANE (UNII: 918X1OUF1E) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z) TOCOPHEROL (UNII: R0ZB2556P8) LEVOMENOL (UNII: 24WE03BX2T) ASTAXANTHIN (UNII: 8XPW32PR7I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43219-005-50 1 in 1 BOX 05/05/2018 1 50 mL 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 final part352 05/05/2018 Labeler - Emilia Cosmetics Ltd (600076624) Establishment Name Address ID/FEI Business Operations Emilia Cosmetics Ltd 600076624 manufacture(43219-005)