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NDC 62217-0350-16 Fruit of the Earth 20; 90; 75; 50; 15; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details
Fruit of the Earth 20; 90; 75; 50; 15; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Fruit of the Earth is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Fruit of the Earth, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.
Product Information
| NDC | 62217-0350 |
|---|---|
| Product ID | 62217-350_c80cb090-b903-ac0d-e053-2995a90a1b45 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Fruit of the Earth |
| Proprietary Name Suffix | Sport SPF 50 |
| Non-Proprietary Name | Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 20; 90; 75; 50; 15; 50 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE |
| Labeler Name | Fruit of the Earth, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62217-0350-16 (62217035016)
| NDC Package Code | 62217-350-16 |
|---|---|
| Billing NDC | 62217035016 |
| Package | 30 mL in 1 TUBE (62217-350-16) |
| Marketing Start Date | 2016-07-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4b431c97-a981-6bf2-e054-00144ff8d46c Details
Active ingredients
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)
INGREDIENTS AND APPEARANCE
| FRUIT OF THE EARTH
SPORT SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion |
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| Labeler - Fruit of the Earth, Inc. (079559467) |