NDC | 62217-005-09 |
Set ID | 4bf41c86-0bff-649d-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Fruit of the Earth, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
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
- 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 protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
-
Inactive ingredients
water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), retinyl palmitate (vitamin A), sodium ascorbyl phosphate (vitamin C), calendula officinalis flower extract, symphytum officinale rhizome/root extract, arctium lappa root extract, honey extract, anthemis nobilis flower extract, tilia cordata flower extract, hydrated silica, potassium cetyl phosphate, propylene glycol, retinyl palmitate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH BLOCK UP KIDS SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) ALOE VERA LEAF (UNII: ZY81Z83H0X) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDRATED SILICA (UNII: Y6O7T4G8P9) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) TROLAMINE (UNII: 9O3K93S3TK) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLPARABEN (UNII: 3QPI1U3FV8) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) HONEY (UNII: Y9H1V576FH) TILIA CORDATA FLOWER (UNII: CFN6G1F6YK) COMFREY ROOT (UNII: M9VVZ08EKQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-005-09 88 mL in 1 TUBE; Type 0: Not a Combination Product 03/30/2017 2 NDC:62217-005-16 30 mL in 1 TUBE; Type 0: Not a Combination Product 09/29/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/29/2014 Labeler - Fruit of the Earth, Inc. (079559467)