Label: STUDIO FIX FLUID BROAD SPECTRUM SPF 15- octinoxate, titanium dioxide emulsion
- NDC Code(s): 40046-0082-1
- Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 10, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- USE
- WARNINGS
-
Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every two 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 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
- children under 6 months of age: ask a doctor
-
Inactive Ingredients
WATER\AQUA\EAU,METHYL TRIMETHICONE,DIMETHICONE,TRIMETHYLSILOXYSILICATE,PEG-10 DIMETHICONE,BUTYLENE GLYCOL,ISODODECANE,POLYETHYLENE,CETYL PEG/PPG-10/1 DIMETHICONE,MAGNESIUM SULFATE,ALGAE EXTRACT,LAMINARIA SACCHARINA EXTRACT,SODIUM HYALURONATE,SALIX NIGRA (WILLOW) BARK EXTRACT,TOCOPHERYL ACETATE,CAFFEINE,LECITHIN,HYDROGENATED LECITHIN,DISTEARDIMONIUM HECTORITE,SILICA,XANTHAN GUM,DIMETHICONE CROSSPOLYMER,TRIETHOXYCAPRYLYLSILANE,DIMETHICONE/PEG-10/15 CROSSPOLYMER,METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER,SORBITAN SESQUIOLEATE,SALICYLIC ACID,SODIUM CITRATE,LAURETH-7,METHYLDIHYDROJASMONATE,PROPYLENE CARBONATE,ALUMINA,DIPROPYLENE GLYCOL,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,BHT,PHENOXYETHANOL,SORBIC ACID,CHLOROXYLENOL, [+/- TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499)] <ILN50543>
- Other Information
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
STUDIO FIX FLUID BROAD SPECTRUM SPF 15
octinoxate, titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0082 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 30 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISODODECANE (UNII: A8289P68Y2) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) CHLOROXYLENOL (UNII: 0F32U78V2Q) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N) SALIX NIGRA BARK (UNII: QU52J3A5B3) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) SORBIC ACID (UNII: X045WJ989B) XANTHAN GUM (UNII: TTV12P4NEE) HYALURONATE SODIUM (UNII: YSE9PPT4TH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM CITRATE (UNII: 1Q73Q2JULR) DIPROPYLENE GLYCOL (UNII: E107L85C40) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CAFFEINE (UNII: 3G6A5W338E) LAURETH-7 (UNII: Z95S6G8201) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0082-1 1 in 1 CARTON 05/12/2023 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/12/2023 Labeler - MAKEUP ART COSMETICS (010597206) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd 202952982 manufacture(40046-0082) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 manufacture(40046-0082) , pack(40046-0082) , label(40046-0082)
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