NDC | 63049-101-23, 63049-101-25 |
Set ID | 277c4c8c-f771-4e33-83a5-2aa773cf49af |
Category | HUMAN OTC DRUG LABEL |
Packager | European Perfume Works Co.L.L.C. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Keep out of reach of children.
- Uses
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply
-after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours- 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 of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
Inactive Ingredients
amyl cinnamal, ascorbyl palmitate, benzyl alcohol, butylparaben, C12-15 alkyl benzoate,
carbomer, ceteareth-20, cetearyl alcohol, ethylparaben, fragrance, glyceryl stearate, glyceryl
stearate SE, isobutylparaben, linalool, methylparaben, PEG-100 stearate, phenoxyethanol,
propylene glycol, propylparaben, sodium hydroxide, sodium cetearyl sulfate, tetrasodium
EDTA, tocopheryl acetate, water.
- Other Information
- Questions or Comments?
- USA Distributor
- Packaging
-
INGREDIENTS AND APPEARANCE
EAD
avobenzone,homosalate,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63049-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.44 g in 120 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2.40 g in 120 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 6.00 g in 120 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.20 g in 120 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) ASCORBYL PALMITATE (UNII: QN83US2B0N) BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER 934 (UNII: Z135WT9208) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLPARABEN (UNII: 14255EXE39) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) LINALOOL, (+/-)- (UNII: D81QY6I88E) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) EDETATE SODIUM (UNII: MP1J8420LU) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63049-101-23 120 mL in 1 TUBE; Type 0: Not a Combination Product 03/18/2014 2 NDC:63049-101-25 95 mL in 1 TUBE; Type 0: Not a Combination Product 11/12/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/18/2014 Labeler - European Perfume Works Co.L.L.C. (851151050) Establishment Name Address ID/FEI Business Operations European Perfume Works Co.L.L.C. 851151050 manufacture(63049-101)