LACE FUTURE RESIST BROAD SPECTRUM SPF 20 FOUNDATION DELILAH- titanium dioxide lotion

Lace Future Resist Broad Spectrum SPF 20 Foundation by

Drug Labeling and Warnings

Lace Future Resist Broad Spectrum SPF 20 Foundation 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 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

Delilah

Time Frame Future resist Foundation Broad Spectrum SPF 20    Lace

Fond de Teint SPF 20 Anti Vieillissement

Foundation Sunscreen

1.28 Fl OZ./36 ml

INGREDIENTS AND APPEARANCE

LACE FUTURE RESIST BROAD SPECTRUM SPF 20 FOUNDATION  DELILAH
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69000-019
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: 69000-019-02	1 in 1 CARTON
1	NDC: 69000-019-01	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(69000-019)