NDC | 43219-018-30 |
Set ID | eb525b0b-522c-45ad-a062-c213b38555ee |
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
Inactive ingredients Water, Dimethicone, Trisiloxanane, Isononyl Isononanoate, Cetyl Alcohol,
Glycerin, Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,
PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Dimethicone Crosspolymer, Xanthan Gum,
Tocopheryl Acetate (Vitamin E), Polysorbate 20,
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Disodium EDTA, Sodium Hydroxide, BHT, Hyaluronic Acid
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VISAGE ENVY FACIAL MOISTURIZING SPF30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43219-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.86 g in 236.59 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3.55 g in 236.59 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.55 g in 236.59 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.77 g in 236.59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRISILOXANE (UNII: 9G1ZW13R0G) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) STEARETH-21 (UNII: 53J3F32P58) NYLON-12 (UNII: 446U8J075B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 20 (UNII: 7T1F30V5YH) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYALURONIC ACID (UNII: S270N0TRQY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43219-018-30 1 in 1 BOX 05/05/2018 1 88 mL in 1 BOTTLE; 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(43219-018)