NDC | 63049-105-24 |
Set ID | 462a5f2f-ee05-44fb-9e88-796223a58d87 |
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
Acrylates/C10-30 alkyl acrylate crosspolymer, ascorbyl palmitate, aloe barbadensis leaf juice, butylparaben, C12-15 alkyl benzoate, cetearyl alcohol, carbomer, ceteareth-20, ethylparaben, fragrance, glyceryl stearate SE, glyceryl stearate, hydorxypropyl methylcellulose, isobutylparaben, linalool, methylparaben, propylene glycol, PEG-100 stearate, PEG-60 almond glycerides, phenoxyethanol, propylparaben, rosa moschata seed oil, sodium cetearyl sulfate, sodium hydroxide, tocopheryl acetate, tetrasodium EDTA, water
- Other Information
- Questions or comments?
- Packaging
-
INGREDIENTS AND APPEARANCE
EAD KIDS
avobenzone, homosalate, octocrylene, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63049-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.64 g in 88 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8.80 g in 88 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.40 g in 88 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.40 g in 88 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4.40 g in 88 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLPARABEN (UNII: 3QPI1U3FV8) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) ETHYLPARABEN (UNII: 14255EXE39) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) LINALOOL, (+/-)- (UNII: D81QY6I88E) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG-100 STEARATE (UNII: YD01N1999R) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ROSA MOSCHATA SEED OIL (UNII: T031ZE559T) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) SODIUM HYDROXIDE (UNII: 55X04QC32I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE SODIUM (UNII: MP1J8420LU) 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:63049-105-24 88 mL in 1 TUBE; Type 0: Not a Combination Product 12/21/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/21/2014 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(63049-105)