Label: FRUIT OF THE EARTH, INC. ULTRA SPF 50 MOISTURIZING SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 62217-006-03
- Packager: Fruit of the Earth, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 28, 2017
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
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Inactive ingredients
water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, aloe barbadensis leaf juice, arnica montana flower extract, chamomilla recutita (matricaria) flower extract, geranium maculatum extract, cucumis sativus (cucmber) fruit extract, euphrasia officinalis extract, tilia cordata flower extract, althaea officinalis root extract, yucca schidigera leaf/root/stem extract, dicetyl phosphate, tocopherol acetate, sodium ascorbyl phosphate, hydrated silica, potassium cetyl phosphate propylene glycol, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)
- Questions or comments?
- Fruit of the Earth, Inc. Ultra SPF 50 Moisturizing Sunscreen Lotion
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH, INC. ULTRA SPF 50 MOISTURIZING SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-006 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 OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 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 Inactive Ingredients Ingredient Name Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CHAMOMILE (UNII: FGL3685T2X) GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) CUCUMBER (UNII: YY7C30VXJT) EUPHRASIA STRICTA (UNII: C9642I91WL) TILIA CORDATA FLOWER (UNII: CFN6G1F6YK) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) YUCCA SCHIDIGERA (UNII: 08A0YG3VIC) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) HYDRATED SILICA (UNII: Y6O7T4G8P9) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-006-03 88 mL in 1 TUBE; Type 0: Not a Combination Product 05/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/12/2017 Labeler - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(62217-006)