NDC | 62217-186-12 |
Set ID | b3dd42b7-5ee6-4278-863b-88fe7f0be1d5 |
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
- ASK DOCTOR
- 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 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
- Other information
-
Inactive ingredients
water (aqua), C12-15 alkyl benzoate, PEG-8, acrylates/C12-22 alkyl methacrylate copolymer, cetearyl alcohol, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), sodium ascorbyl phosphate (vitamin C), chamomilla recutita (matricaria) flower extract, citrus limon (lemon) peel extract, geranium maculatum extract, calendula officianalis leaf extract, propylene glycol, potassium cetyl phosphate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, hydrated silica, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)
- Questions or Comments?
- Principal Package Display Fruit of the Earth Block Up! Broad Spectrum Sport SPF 50 8 FL OZ (237mL) NDC: 62217-186-12
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH BLOCK UP BROAD SPECTRUM SPORT SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-186 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CETEARETH-10 PHOSPHATE (UNII: 099WOY1SA3) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CHAMOMILE (UNII: FGL3685T2X) LEMON PEEL (UNII: 72O054U628) GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) SAGE (UNII: 065C5D077J) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) HYDRATED SILICA (UNII: Y6O7T4G8P9) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-186-12 237 mL in 1 TUBE; Type 0: Not a Combination Product 02/05/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/05/2015 Labeler - FRUIT OF THE EARTH, INC. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(62217-186)