NDC | 62217-021-09 |
Set ID | 50ff1ca9-7c04-06b5-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
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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Inactive ingredients
water (aqua), C12-15 alkyl benzoate, PEG-8,
acrylates/C12-22 alkyl methacrylate copolymer, cetearyl alcohol (and) dicetyl
phosphate (and) ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate
(vitamin E), retinyl palmitate (vitamin A), sodium ascorbyl phosphate (vitamin C), arnica
montana flower extract (and) chamomilla recutita (matricaria) flower extract (and)
geranium maculatum extract (and) cucumis sativus (cucumber) fruit extract (and)
euphrasia officinalis extract (and) tilia cordata flower extract (and) althaea officinalis
root extract (and) yucca schidigera extract, hydrated silica, potassium cetyl phosphate,
propylene glycol, phenoxyethanol (and) methylparaben (and) propylparaben (and)
butylparaben (and) ethylparaben (and) isobutylparaben, acrylates/C10-30 alkyl acrylate
crosspolymer, disodium EDTA, fragrance (parfum) - Fruit of the Earth, Inc. Block Up! SPF 30 Sunscreen Lotion
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH BLOCK UP SPF 30 SUNSCREEN
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) TILIA CORDATA FLOWER (UNII: CFN6G1F6YK) YUCCA SCHIDIGERA (UNII: 08A0YG3VIC) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) ETHYLPARABEN (UNII: 14255EXE39) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) CUCUMBER (UNII: YY7C30VXJT) EUPHRASIA STRICTA (UNII: C9642I91WL) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) HYDRATED SILICA (UNII: Y6O7T4G8P9) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-021-09 88 mL in 1 TUBE; Type 0: Not a Combination Product 06/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/02/2017 Labeler - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(62217-021)