Label: SUNFORGETTABLE TINT DU SOLEIL FOUNDATION SPF 30 SUNSCREEN- titanium dioxide and zinc oxide liquid
- NDC Code(s): 68078-004-02, 68078-004-05
- Packager: Colorescience
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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.
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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.
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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:
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SUNFORGETTABLE TINT DU SOLEIL FOUNDATION SPF 30 SUNSCREEN
titanium dioxide and zinc oxide liquidProduct 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) YLANG-YLANG 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) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (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 Drug M020 10/05/2015 Labeler - Colorescience (128731929)
