SUNFORGETTABLE TINT DU SOLEIL FOUNDATION SPF 30 SUNSCREEN- titanium dioxide and zinc oxide liquid

Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen by

Drug Labeling and Warnings

Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Colorescience. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 4.8%	Sunscreen
Zinc Oxide 6.7%	Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
• Reapply:
  • After 40 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
• Children under 6 months: ask a doctor.
• 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 value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.– 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredients

Cyclopentasiloxane, Water, Mica, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Butylene Glycol, Silica, Tocopheryl Acetate, Glyceryl Linoleate, Glyceryl Linolenate, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Ceramide NP, Milk Lipids (Lactis Lipida), Ahnfeltia Concinna Extract, Dimethiconol, Jojoba Esters, Lauroyl Lysine, Glyceryl Behenate/Eicosadioate, Pelargonium Graveolens Flower Oil, Cananga Odorata Flower Oil, Fusanus Spicatus Wood Oil, Sorbitol, Lecithin, Polysorbate 20, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Alumina, Xanthan Gum, Carbomer, BHT, Sodium Lactate, Disodium EDTA, Sorbic Acid, Sodium Benzoate, Chlorphenesin, Sodium Dehydroacetate, Chlorhexedine Digluconate, Glyceryl Caprylate, Caprylyl Glycol, Phenoxyethanol, Phenethyl Alcohol, Farnesol, Linalool, Iron Oxides (CI 77491, CI 77492, CI 77499)

Other information:

• Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 866.426.5673

SPL UNCLASSIFIED SECTION

Distributed in USA by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

colorescience®

TINT DU
SOLEIL™

WHIPPED FOUNDATION
Creamy and lightweight
Multi-vitamin infused
Water resistant
(40 minutes)

30
Broad Spectrum
SPF 30
Sunscreeen

1 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

SUNFORGETTABLE TINT DU SOLEIL FOUNDATION SPF 30 SUNSCREEN 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	48 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	67 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAUROYL LYSINE (UNII: 113171Q70B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
AHNFELTIOPSIS CONCINNA (UNII: SMF2K46G8D)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
ALUMINUM OXIDE (UNII: LMI26O6933)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITOL (UNII: 506T60A25R)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
COW MILK FAT (UNII: 463JZS0XJ3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CANANGA OIL (UNII: 8YOY78GNNX)
GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
SODIUM LACTATE (UNII: TU7HW0W0QT)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
JOJOBA OIL (UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
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: 68078-004-05	1 in 1 CARTON	10/05/2015
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68078-004-02	1 mL in 1 PACKET; Type 0: Not a Combination Product	10/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/05/2015

Labeler - Colorescience (128731929)