Label: FRUIT OF THE EARTH, INC. LUV THAT SUN SPF 30 NATURAL MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 62217-001-13
- 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 February 6, 2018
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- Active ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
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Inactive ingredients
Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1, Dimethicone, Lauryl PEG-8 Dimethicone, Glycerin, Aloe Barbadensis, Leaf Juice, Sodium Chloride, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Ethylhexyl Methoxycrylene, Dimethicone, Caprylyl Glycol, PEG-8, Silica, Phenoxyethanol, Triethoxycaprylylsilane, Sodium Citrate, Tocopheryl Acetate, Adansonia Digitata Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Hibiscus Sabdariffa Flower Extract, Lens Esculenta (Lentil) Fruit Extract, Phragmites Communis Extract, Polysorbate 20, Pyrus Malus (Apple) Fruit Extract, Poria Cocos Extract, Scutellaria Alpina Flower/Leaf/Stem Extract, Trifolium Pratense (Clover) Leaf Extract.
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH, INC. LUV THAT SUN SPF 30 NATURAL MINERAL SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40.4625 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 31.16 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4) ISOHEXADECANE (UNII: 918X1OUF1E) SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYSORBATE 20 (UNII: 7T1F30V5YH) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LENS CULINARIS FRUIT (UNII: ZYZ076G9JH) FU LING (UNII: XH37TWY5O4) APPLE (UNII: B423VGH5S9) TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P) WATERMELON (UNII: 231473QB6R) WATER (UNII: 059QF0KO0R) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-001-13 100 mL in 1 TUBE; Type 0: Not a Combination Product 02/06/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/06/2018 Labeler - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(62217-001)