Label: FRUIT OF THE EARTH VITAMIN E SPF 15 SUNSCREEN DAILY DEFENSE MOISTURIZER- avobenzone, octinoxate, octocrylene, oxybenzone lotion
- NDC Code(s): 62217-252-33
- Packager: FRUIT OF THE EARTH, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 21, 2023
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- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- 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, aloe barbadensis leaf juice, c12-15 alkyl benzoate, cyclopentasiloxane, phenyl trimethicone, acrylates copolymer, propylene glycol, stearic acid, glyceryl stearate, PEG 100 stearate, tocopheryl acetate (vitamin E), acrylates/steareth-20 methacrylate copolymer, triethanolamine, citrus limon (lemon) fruit oil, methylparaben, propylparaben, ethylparaben, butylparaben, phenoxyethanol, isobutylparaben, disodium EDTA, fragrance, titanium dioxide.
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH VITAMIN E SPF 15 SUNSCREEN DAILY DEFENSE MOISTURIZER
avobenzone, octinoxate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-252 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) LEMON OIL (UNII: I9GRO824LL) STEARIC ACID (UNII: 4ELV7Z65AP) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLPARABEN (UNII: 3QPI1U3FV8) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-252-33 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/13/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 06/13/2005 Labeler - FRUIT OF THE EARTH, INC. (079559467)