NDC | 62217-350-09, 62217-350-11, 62217-350-16 |
Set ID | 4b431c97-a981-6bf2-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 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
• 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
• children under 6 months: Ask a doctor - Other information
-
Inactive ingredients
water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, aloe barbadensis leaf juice, anthemis nobilis flower extract, citrus limon (lemon) peel extract, geranium maculatum extract, calendula officinalis flower extract, salvia officinalis (sage) leaf extract, arctium lappa root extract, melissa officinalis leaf extract, juglans nigra (black walnut) leaf extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, propylene glycol, potassium cetyl phosphate, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, hydrated silica, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SPORT SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) JUGLANS NIGRA LEAF (UNII: I2OQ2W1NI2) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDRATED SILICA (UNII: Y6O7T4G8P9) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) LEMON PEEL (UNII: 72O054U628) SAGE (UNII: 065C5D077J) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-350-16 30 mL in 1 TUBE; Type 0: Not a Combination Product 07/20/2016 2 NDC:62217-350-09 88 mL in 1 TUBE; Type 0: Not a Combination Product 07/20/2016 3 NDC:62217-350-11 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/20/2016 Labeler - Fruit of the Earth, Inc. (079559467)