Label: FACE VALUES RADIANT FACIAL DAILY MOISTURIZER SPF 15 SUNSCREEN- avobenzone, octinoxate, octisalate lotion
- NDC Code(s): 63940-066-04, 63940-066-05
- Packager: HARMON STORES, 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 March 24, 2020
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: ask a doctor
- 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
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Inactive ingredients
water, C12-15 alkyl benzoate, glycerin, cetearyl alcohol, dimethicone, glycine soja (soybean) seed extract, bis-phenylpropyl dimethicone, arachidyl alcohol, phenoxyethanol, cetearyl glucoside, panthenol, benzyl alcohol, ethylene/acrylic acid copolymer, behenyl alcohol, steareth-2, fragrance, steareth-21, polyacrylamide, polymethyl methacrylate, arachidyl glucoside, disodium EDTA, methylparaben, C13-14 isoparaffin, ethylparaben, butylparaben, laureth-7, benzalkonium chloride, propylparaben, isobutylparaben, iodopropynyl butylcarbamate, BHT, PEG-4 dilaurate, PEG-4 laurate, PEG-4, silica, mica, titanium dioxide.
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INGREDIENTS AND APPEARANCE
FACE VALUES RADIANT FACIAL DAILY MOISTURIZER SPF 15 SUNSCREEN
avobenzone, octinoxate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-066 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) SOYBEAN (UNII: L7HT8F1ZOD) BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) PANTHENOL (UNII: WV9CM0O67Z) BENZYL ALCOHOL (UNII: LKG8494WBH) ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I) DOCOSANOL (UNII: 9G1OE216XY) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ETHYLPARABEN (UNII: 14255EXE39) BUTYLPARABEN (UNII: 3QPI1U3FV8) LAURETH-7 (UNII: Z95S6G8201) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PEG-4 DILAURATE (UNII: KCR71CW036) PEG-4 LAURATE (UNII: AYF4VM3N1Z) POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63940-066-05 1 in 1 CARTON 10/27/2010 1 NDC:63940-066-04 118.3 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/27/2010 Labeler - HARMON STORES, INC. (804085293) Registrant - FRUIT OF THE EARTH, INC. (079559467) Establishment Name Address ID/FEI Business Operations FRUIT OF THE EARTH, INC. 008193513 manufacture(63940-066)
