TIME FRAME FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 TRUFFLE DELILAH COSMETICS- avobenzone, octinoxate, octocrylene solution

Time Frame Future Resist Foundation Broad Spectrum SPF 20 Truffle by

Drug Labeling and Warnings

Time Frame Future Resist Foundation Broad Spectrum SPF 20 Truffle 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

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)].

PRINCIPAL DISPLAY PANEL

delilah

Time Frame

Future Resist Foundation Broad Spectrum SPF 20  Truffle

Fond de Teint SPF 20

Anti Vieillissement

Foundation Sunscreen

1.28 Fl Oz/ 38 ml

INGREDIENTS AND APPEARANCE

TIME FRAME FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 TRUFFLE  DELILAH COSMETICS
avobenzone, octinoxate, octocrylene solution

Product 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)