Label: NUTMEG FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 FOUNDATION DELILAH- titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69000-023-01, 69000-023-02 - 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 December 26, 2014
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
Titanium Dioxide 5% Sunscreen
Uses
Helps prevent Sunburn
If used as directed with other sun protection measures (see Directions), decrease the risk of of skin cancer and early skin aging caused by the sun.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor 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 to a 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 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 from 10 a.m. - 2p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months ask doctor.
Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-3, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NUTMEG FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 FOUNDATION DELILAH
titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69000-023 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) TROPOLONE (UNII: 7L6DL16P1T) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) 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:69000-023-02 1 in 1 CARTON 1 NDC:69000-023-01 38 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/13/2014 Labeler - Delilah Cosmetics (219906475) Registrant - Delilah Cosmetics (219906475) Establishment Name Address ID/FEI Business Operations Gotha Cosmetics SRL 378071679 manufacture(69000-023)
