Label: G.M. COLLIN FPS-SPF 45 UVA-UVB TINTED SUNSCREEN- zinc oxide, titanium dioxide cream
- NDC Code(s): 64127-244-01
- Packager: LABORATOIRES DERMO-COSMETIK INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 1, 2023
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- SPL UNCLASSIFIED SECTION
- Uses
- Warnings
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Directions
Adults over 18 years old:
• apply liberally 15 minutes before sun exposure.
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease 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. - Other information
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Inactive ingredients
DIMETHICONE, PEG-10 DIMETHICONE, HEXYL LAURATE, COPERNICIA CERIFERA (CARNAUBA) WAX / CIRE DE CARNAUBA, POLYSILICONE-11, ISONONYL ISONONANOATE, TRIHYDROXYSTEARIN, POLYGLYCERYL-4 ISOSTEARATE, POLYMETHYLSILSESQUIOXANE, STEARIC ACID / ACIDE STÉARIQUE, IRON OXIDES / OXYDES DE FER, PRUNUS ARMENIACA (APRICOT) KERNEL OIL / HUILE DE NOYAU D’ABRICOT, TOCOPHERYL ACETATE, LUPINUS ALBUS SEED OIL / HUILE DE GRAINES DE LUPIN, TRITICUM VULGARE (WHEAT) GERM OIL UNSAPONIFIABLES / HUILES INSAPONIFIABLES DE GERME BLÉ, SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT / EXTRAIT DE FRUIT/FEUILLE/TIGE DE TOMATE, TOCOPHEROL, ALUMINA, ETHYLENE BRASSYLATE, ORYZA SATIVA (RICE) BRAN WAX / CIRE DE SON DE RIZ, TRIETHOXYCAPRYLYLSILANE.
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
G.M. COLLIN FPS-SPF 45 UVA-UVB TINTED SUNSCREEN
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64127-244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 11.2 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.4 g in 100 g Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) SOLANUM LYCOPERSICUM FRUITING TOP (UNII: X636CG4BH0) RICE BRAN (UNII: R60QEP13IC) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) APRICOT KERNEL OIL (UNII: 54JB35T06A) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LUPINUS ALBUS SEED OIL (UNII: 958BJW095Q) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WHEAT GERM OIL UNSAPONIFIABLES (UNII: 6AXM7XCV3D) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) HEXYL LAURATE (UNII: 4CG9F9W01Q) CARNAUBA WAX (UNII: R12CBM0EIZ) PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) STEARIC ACID (UNII: 4ELV7Z65AP) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64127-244-01 1 in 1 CARTON 01/01/2024 1 50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2024 Labeler - LABORATOIRES DERMO-COSMETIK INC. (249335480)
