TIME FRAME FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 DELILAH COSMETICS- titanium dioxide liquid

Time Frame Future Resist Foundation Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Time Frame Future Resist Foundation Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Delilah Cosmetics, Gotha Cosmetics SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

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-4, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides).

PRINCIPAL DISPLAY PANEL

Delilah

Time Frame
Future Resist Foundation

Broad Spectrum SPF 20

Fond de Teint SPF 20
Anti Vieilssement

INGREDIENTS AND APPEARANCE

TIME FRAME FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20  DELILAH COSMETICS
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69000-010
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)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
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: 69000-010-02	1 in 1 CARTON
1	NDC: 69000-010-01	38 mL in 1 TUBE

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(69000-010)