Label: SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (BEIGE) SUNSCREEN- octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (HONEY) SUNSCREEN- octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (BLUSH) SUNSCREEN- octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58892-721-65, 58892-722-65, 58892-723-65 - Packager: Fallien Cosmeceuticals, LTD.
- 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 January 14, 2013
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 Ingredients:
- Purpose
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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:
- Other Information:
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Directions:
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant product if swimming or sweating.
- Reapply 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 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
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Inactive Ingredients:
Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, Caramel, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Methylparaben, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
Manufactured exclusively for Fallien Ltd., West Norriton, PA Made in USA
Solar Protection Formula offers the most complete protection from UVB/UVA available, and is essential for the medically light sensitive and for those concerned with the damaging effects of the sun.
- Principal Display Panel – Beige Carton Label
- Principal Display Panel – Honey Carton Label
- Principal Display Panel – Blush Carton Label
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INGREDIENTS AND APPEARANCE
SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (BEIGE) SUNSCREEN
octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-721 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 69 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 81 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 46 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 115 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 39 mg in 1 mL Inactive Ingredients Ingredient Name Strength Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Ascorbyl Palmitate (UNII: QN83US2B0N) .BETA.-Carotene (UNII: 01YAE03M7J) Butylparaben (UNII: 3QPI1U3FV8) Caramel (UNII: T9D99G2B1R) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Isobutylparaben (UNII: 0QQJ25X58G) Isopropylparaben (UNII: A6EOX47QK0) Linoleamidopropyl Dimethylamine (UNII: W142CF4WLF) Octyldodecyl Neopentanoate (UNII: X8725R883T) Phenoxyethanol (UNII: HIE492ZZ3T) Maritime Pine (UNII: 50JZ5Z98QY) Polysorbate 20 (UNII: 7T1F30V5YH) Propylene Glycol (UNII: 6DC9Q167V3) Sorbitan Monolaurate (UNII: 6W9PS8B71J) Talc (UNII: 7SEV7J4R1U) Tocopherol (UNII: R0ZB2556P8) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-721-65 1 in 1 CARTON 1 59 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/1994 SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (HONEY) SUNSCREEN
octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-722 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 69 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 81 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 46 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 115 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 39 mg in 1 mL Inactive Ingredients Ingredient Name Strength Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Ascorbyl Palmitate (UNII: QN83US2B0N) .BETA.-Carotene (UNII: 01YAE03M7J) Butylparaben (UNII: 3QPI1U3FV8) Caramel (UNII: T9D99G2B1R) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Isobutylparaben (UNII: 0QQJ25X58G) Isopropylparaben (UNII: A6EOX47QK0) Linoleamidopropyl Dimethylamine (UNII: W142CF4WLF) Octyldodecyl Neopentanoate (UNII: X8725R883T) Phenoxyethanol (UNII: HIE492ZZ3T) Maritime Pine (UNII: 50JZ5Z98QY) Polysorbate 20 (UNII: 7T1F30V5YH) Propylene Glycol (UNII: 6DC9Q167V3) Sorbitan Monolaurate (UNII: 6W9PS8B71J) Talc (UNII: 7SEV7J4R1U) Tocopherol (UNII: R0ZB2556P8) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-722-65 1 in 1 CARTON 1 59 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/1994 SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (BLUSH) SUNSCREEN
octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-723 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 69 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 81 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 46 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 115 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 39 mg in 1 mL Inactive Ingredients Ingredient Name Strength Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Ascorbyl Palmitate (UNII: QN83US2B0N) .BETA.-Carotene (UNII: 01YAE03M7J) Butylparaben (UNII: 3QPI1U3FV8) Caramel (UNII: T9D99G2B1R) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Isobutylparaben (UNII: 0QQJ25X58G) Isopropylparaben (UNII: A6EOX47QK0) Linoleamidopropyl Dimethylamine (UNII: W142CF4WLF) Octyldodecyl Neopentanoate (UNII: X8725R883T) Phenoxyethanol (UNII: HIE492ZZ3T) Maritime Pine (UNII: 50JZ5Z98QY) Polysorbate 20 (UNII: 7T1F30V5YH) Propylene Glycol (UNII: 6DC9Q167V3) Sorbitan Monolaurate (UNII: 6W9PS8B71J) Talc (UNII: 7SEV7J4R1U) Tocopherol (UNII: R0ZB2556P8) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-723-65 1 in 1 CARTON 1 59 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/1994 Labeler - Fallien Cosmeceuticals, LTD. (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(58892-721, 58892-722, 58892-723) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging 809172885 MANUFACTURE(58892-721, 58892-722, 58892-723)