NDC | 62217-017-15 |
Set ID | 504b4763-a92e-2760-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
- STOP USE
- 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 officinalis flower extract, salvia officinalis
(sage) leaf extract, arctium lappa root extract, melissa officinalis 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?
- Fruit of the Earth Block Up! Sport SPF 50 Moisturizing Sunscreen Lotion
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH BLOCK UP SPORT SPF 50 MOISTURIZING SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 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 OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 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) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON (UNII: 24RS0A988O) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SAGE (UNII: 065C5D077J) METHYLPARABEN (UNII: A2I8C7HI9T) TROLAMINE (UNII: 9O3K93S3TK) 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) HYDRATED SILICA (UNII: Y6O7T4G8P9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-017-15 177 mL in 1 TUBE; Type 0: Not a Combination Product 05/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/24/2017 Labeler - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(62217-017)