NUTMEG FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 FOUNDATION DELILAH- titanium dioxide liquid 
Delilah Cosmetics

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.

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Nutmeg Delilah Time Frame Future Resist foundation

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).

Delilah

Time Frame Future resist Foundation Broad Spectrum SPF 20       Nutmeg

Fond de Teint SPF 20 Anti Vieillissement

Foundation Sunscreen

1.28 Fl OZ./36 ml

Secondary

Primary

NUTMEG FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 FOUNDATION  DELILAH
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69000-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69000-023-021 in 1 CARTON
1NDC:69000-023-0138 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/13/2014
Labeler - Delilah Cosmetics (219906475)
Registrant - Delilah Cosmetics (219906475)
Establishment
NameAddressID/FEIBusiness Operations
Gotha Cosmetics SRL378071679manufacture(69000-023)

Revised: 12/2014
Document Id: 8420e2c4-f383-4ae0-a536-3fd23236af1f
Set id: 10de89b2-a1b6-4062-a8b2-b18998130159
Version: 2
Effective Time: 20141226
 
Delilah Cosmetics