FRUIT OF THE EARTH, INC. ULTRA SPF 50 MOISTURIZING SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion 
Fruit of the Earth, Inc.

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.

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Fruit of the Earth, Inc. Ultra SPF 50 Moisturizing Sunscreen Lotion

Active ingredients

Avobenzone 2.0%, Homosalate 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5%, Oxybenzone 5.0%

Purpose

Sunscreen

Uses

Warnings

​For external use only

​Do not use ​​on damaged or broken skin

​When using this product​ keep out of eyes. Rinse with water to remove.

​Stop use and ask a doctor if rash occurs.​

​Keep out of reach of children. ​If product is swallowed, get medical help right away.

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

Other information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

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?

Call toll free 1-800-527-7731

Fruit of the Earth, Inc. Ultra SPF 50 Moisturizing Sunscreen Lotion

Representative Image

FRUIT OF THE EARTH, INC.  ULTRA SPF 50 MOISTURIZING SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-006-0388 mL in 1 TUBE; Type 0: Not a Combination Product05/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/12/2017
Labeler - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-006)

Revised: 8/2017
Document Id: 57d2549e-faf4-1791-e053-2a91aa0a7f63
Set id: 4f5aedec-6eba-461e-e054-00144ff8d46c
Version: 2
Effective Time: 20170828
 
Fruit of the Earth, Inc.