Label: TIME FRAME FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 TRUFFLE DELILAH COSMETICS- avobenzone, octinoxate, octocrylene solution
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Contains inactivated NDC Code(s)
NDC Code(s): 69000-011-01, 69000-011-02 - Packager: Delilah Cosmetics
- 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 April 27, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 0.6% Sunscreen
Octinoxate 3% Sunscreen
Octocrylene 3% Sunscreen
Uses
Helps prevent Sunburn
If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.
Keep out of reach of children. If product is swallowed, get medical help contact a Poison Control Center right away.
Stop use and ask a dcotor if rash occurs.
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.
Directions
Apply foundation liberally to clean face for Broad Spectrum protection. Reapply as needed.
This is not a primary Sunscreen. For further protection by a primary Sunscreen follow directions below.
Apply primary Sunscreen liberally 15 minutes before sun exposure
Reapply 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 15 or higher and other sun protection measures including:
Limit time in the sun, especially 10 a.m. - 2 p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months ask doctor
Caprylic/Capric TriglycerideInactive Ingredients: Water/Aqua, Cyclomethicone, Butyloctyl Salicylate, Butylene Glycol, Hydrogenated Polyisobutene, Cetyl PEG/PPG-10/1 Dimethicone, Titanium Dioxide, Caprylic/Capric Triglyceride, Isoamyl Laurate, Glyceryl Tribehenate/Isostearate/Eicosadioate, Polymethyl Methacrylate, Isopentyldiol, Lauryl PEG-8 Dimethicone, Phenoxyethanol, Sucrose Acetate Isobutyrate Sodium Chloride, Disteardimonium Hectorite, Polyglyceryl-4-Isostearate, Stearalkonium Hectorite, Triethoxycaprylylsilane, Sodium Dehydroacetate, Tocopheryl Acetate, Propylene Carbonate, Alumina, Trisodium Ethylenediamine Dissucinate, Tropolone, Tripeptide-3, Hexapeptide-3 [May Contain (+/-): CI 77491 (Iron Oxides), CI 77492 (Iron Oxide), CI 77499 (Iron Oxides)].
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INGREDIENTS AND APPEARANCE
TIME FRAME FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 TRUFFLE DELILAH COSMETICS
avobenzone, octinoxate, octocrylene solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69000-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.6 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOAMYL LAURATE (UNII: M1SLX00M3M) GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE (UNII: 3Y9NJ5Z7E5) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) ISOPENTYLDIOL (UNII: 19NOL5474Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) SUCROSE ACETATE ISOBUTYRATE (UNII: H5KI1C3YTV) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALUMINUM OXIDE (UNII: LMI26O6933) TROPOLONE (UNII: 7L6DL16P1T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69000-011-02 1 in 1 CARTON 1 NDC:69000-011-01 38 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/07/2014 Labeler - Delilah Cosmetics (219906475) Registrant - Delilah Cosmetics (219906475) Establishment Name Address ID/FEI Business Operations Gotha Cosmetics SRL 378071679 manufacture(69000-011)
