Label: STUDIO FIX FLUID BROAD SPECTRUM SPF 15 WITH ENRICHED ANTI-OXIDANT COMPLEX- octinoxate and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0073-1 - Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 2, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply every two hours
- use a water resistant sunscreen if swimming or sweating
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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
- children under 6 months of age: ask a doctor
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inactive ingredients
water/aqua/eau, cyclopentasiloxane, dimethicone, peg-10 dimethicone, butylene glycol, trimethylsiloxysilicate, magnesium sulfate, dimethicone/peg-10/15 crosspolymer, tocopheryl acetate, sodium hyaluronate, algae extract, olea europaea (olive) leaf extract, oryza sativa (rice) bran extract, laminaria saccharina extract, polygonum cuspidatum root extract, lecithin, hydrogenated lecithin, methoxy amodimethicone/silsesquioxane copolymer, silica, peg/ppg-18/18 dimethicone, dimethicone crosspolymer, laureth-7, triethoxycaprylylsilane, xanthan gum, sorbitan sesquioleate, dipropylene glycol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, chloroxylenol, sorbic acid [+/- titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499), chromium oxide greens (ci 77288)] <iln41302>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
STUDIO FIX FLUID BROAD SPECTRUM SPF 15 WITH ENRICHED ANTI-OXIDANT COMPLEX
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0073 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.02775 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.0111 g in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) dimethicone (UNII: 92RU3N3Y1O) butylene glycol (UNII: 3XUS85K0RA) magnesium sulfate (UNII: DE08037SAB) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) hyaluronate sodium (UNII: YSE9PPT4TH) olea europaea leaf (UNII: MJ95C3OH47) rice bran (UNII: R60QEP13IC) saccharina latissima (UNII: 68CMP2MB55) polygonum cuspidatum root (UNII: 7TRV45YZF7) silicon dioxide (UNII: ETJ7Z6XBU4) peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794) laureth-7 (UNII: Z95S6G8201) triethoxycaprylylsilane (UNII: LDC331P08E) xanthan gum (UNII: TTV12P4NEE) sorbitan sesquioleate (UNII: 0W8RRI5W5A) dipropylene glycol (UNII: E107L85C40) pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS) phenoxyethanol (UNII: HIE492ZZ3T) chloroxylenol (UNII: 0F32U78V2Q) sorbic acid (UNII: X045WJ989B) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) chromic oxide (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0073-1 1 in 1 CARTON 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/01/2014 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(40046-0073) , REPACK(40046-0073) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(40046-0073) , REPACK(40046-0073) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0073) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(40046-0073) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0073) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0073) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(40046-0073) , REPACK(40046-0073) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 959338336 MANUFACTURE(40046-0073) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(40046-0073) , REPACK(40046-0073) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0073) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(40046-0073) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center (PALC) 078364654 REPACK(40046-0073) , RELABEL(40046-0073) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(40046-0073)
