Label: FLAWLESS FUTURE MOISTURE- octinoxate, octisalate, oxybenzone and avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-2050-1, 67938-2050-2 - Packager: ELIZABETH ARDEN, 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 November 7, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions For Sunscreen Use:
- Apply liberally 15 minutes before sun exposure
- Reapply:
- at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
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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.
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Inactive Ingredients
WATER/AQUA/EAU, GLYCERIN, DIMETHICONE, ARGANIA SPINOSA KERNEL OIL, C12-15 ALKYL BENZOATE, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETYL ALCOHOL, STEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, ADENOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BISABOLOU CAPRYLYL GLYCOL, CARAMEL, CARBOMER, CERAMIDE1, CERAMIDE3, CERAMIDE6 II, CHOLESTEROL, DIPOTASSIUM GLYCYRRHIZATE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, FUCOSE, GLUCOSE, GLUCURONIC ACID, HYDROLYZED SOY PROTEIN, HYDROLYZED YEAST PROTEIN, JOJOBA ESTERS, KEFIRAN, PANTHENOL, PARFUM/FRAGRANCE, PHYTOSPHINGOSINE, PROPYLENE GLYCOL, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, TOCOPHEROL, XANTHAN GUM, BHT, ALPHA-ISOMETHYLIONONE, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, SODIUM BENZOATE, RED 40 (Cl 16035).
- Other Information
- Questions or comments?
- Principal Display Panel - Box Label
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INGREDIENTS AND APPEARANCE
FLAWLESS FUTURE MOISTURE
octinoxate, octisalate, oxybenzone and avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-2050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.57 g in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.375 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) ARGAN OIL (UNII: 4V59G5UW9X) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) PANTHENOL (UNII: WV9CM0O67Z) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) XANTHAN GUM (UNII: TTV12P4NEE) CHLORPHENESIN (UNII: I670DAL4SZ) LEVOMENOL (UNII: 24WE03BX2T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) ADENOSINE (UNII: K72T3FS567) LINALOOL, (+/-)- (UNII: D81QY6I88E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) CARAMEL (UNII: T9D99G2B1R) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL SALICYLATE (UNII: WAO5MNK9TU) CERAMIDE 3 (UNII: 4370DF050B) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DEXTROSE (UNII: IY9XDZ35W2) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) CERAMIDE 6 II (UNII: F1X8L2B00J) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CHOLESTEROL (UNII: 97C5T2UQ7J) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FUCOSE (UNII: 28RYY2IV3F) GLUCURONIC ACID (UNII: 8A5D83Q4RW) SODIUM BENZOATE (UNII: OJ245FE5EU) SOY PROTEIN (UNII: R44IWB3RN5) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) TOCOPHEROL (UNII: R0ZB2556P8) SOLVENT RED 4 (UNII: EVE9WNU99R) CERAMIDE 1 (UNII: 5THT33P7X7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-2050-1 1 in 1 BOX 1 NDC:67938-2050-2 50 g in 1 JAR; 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 11/07/2014 Labeler - ELIZABETH ARDEN, INC (849222187) Establishment Name Address ID/FEI Business Operations ENGLEWOOD LAB 172198223 MANUFACTURE(67938-2050)
