Solar Protection Formula SPF 60 Tinted Concealer - (Blush)

Manufacturer
Fallien Cosmeceuticals, LTD. | Custom Analytics LLC | Process Technologies & Packaging
Effective date
2013-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:34:16

Label at a glance#

ProductSolar Protection Formula SPF 60 Tinted Concealer - (Beige) Sunscreen
Active ingredientOctinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide
Label structure11 sections

Indications and 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.

Dosage and administration

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 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 includ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6%

Octocrylene 7%

Oxybenzone 4%

Titanium Dioxide 10%

Zinc Oxide 3.4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SHAKE WELL BEFORE USING

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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
  • 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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOLAR

PROTECTION

FORMULA®

TINTED
CONCEALER

SPF 60

Broad Spectrum

UVA/UVB

2 Fl.Oz./59 ml

Principal Display Panel – Beige Carton Label
Principal Display Panel – Beige Carton Label

Principal Display Panel – Honey Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOLAR

PROTECTION

FORMULA®

TINTED
CONCEALER

SPF 60

Broad Spectrum

UVA/UVB

2 Fl.Oz./59 ml

Principal Display Panel – Honey Carton Label
Principal Display Panel – Honey Carton Label

Principal Display Panel – Blush Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOLAR

PROTECTION

FORMULA®

TINTED
CONCEALER

SPF 60

Broad Spectrum

UVA/UVB

2 Fl.Oz./59 ml

Principal Display Panel – Blush Carton Label
Principal Display Panel – Blush Carton Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-721-65Solar Protection Formula SPF 60 Tinted Concealer - (Beige) Sunscreen59 mL in 1 BOTTLELOTION593
58892-721-65Solar Protection Formula SPF 60 Tinted Concealer - (Beige) Sunscreen1 in 1 CARTONLOTION13
58892-722-65Solar Protection Formula SPF 60 Tinted Concealer - (Honey) Sunscreen59 mL in 1 BOTTLELOTION593
58892-722-65Solar Protection Formula SPF 60 Tinted Concealer - (Honey) Sunscreen1 in 1 CARTONLOTION13
58892-723-65Solar Protection Formula SPF 60 Tinted Concealer - (Blush) Sunscreen1 in 1 CARTONLOTION13
58892-723-65Solar Protection Formula SPF 60 Tinted Concealer - (Blush) Sunscreen59 mL in 1 BOTTLELOTION593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-721SOLAR 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 [FALLIEN COSMECEUTICALS, LTD.]3Legacy NDC, 2 package rows20130116_9bd3375f-3df4-4ecc-9185-0157aa0a19dd.zip
58892-722SOLAR 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 [FALLIEN COSMECEUTICALS, LTD.]3Legacy NDC, 2 package rows20130116_9bd3375f-3df4-4ecc-9185-0157aa0a19dd.zip
58892-723SOLAR 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 [FALLIEN COSMECEUTICALS, LTD.]3Legacy NDC, 2 package rows20130116_9bd3375f-3df4-4ecc-9185-0157aa0a19dd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD513
OctocryleneACTIVE INGREDIENT5A68WGF6WM3
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y3
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP3
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z3
OctinoxateACTIVE MOIETY4Y5P7MUD513
OctocryleneACTIVE MOIETY5A68WGF6WM3
OxybenzoneACTIVE MOIETY95OOS7VE0Y3
Titanium DioxideACTIVE MOIETY15FIX9V2JP3
Zinc OxideACTIVE MOIETYSOI2LOH54Z3
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L03
.BETA.-CaroteneINACTIVE INGREDIENT01YAE03M7J3
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ3
Aluminum Starch OctenylsuccinateINACTIVE INGREDIENTI9PJ0O62943
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0N3
ButylparabenINACTIVE INGREDIENT3QPI1U3FV83
CaramelINACTIVE INGREDIENTT9D99G2B1R3
Cetearyl GlucosideINACTIVE INGREDIENT09FUA47KNA3
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S3
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K3
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G6753
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRT3
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F3573
IsobutylparabenINACTIVE INGREDIENT0QQJ25X58G3
IsopropylparabenINACTIVE INGREDIENTA6EOX47QK03
Linoleamidopropyl DimethylamineINACTIVE INGREDIENTW142CF4WLF3
Maritime PineINACTIVE INGREDIENT50JZ5Z98QY3
Octyldodecyl NeopentanoateINACTIVE INGREDIENTX8725R883T3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T3
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YH3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V33
Sorbitan MonolaurateINACTIVE INGREDIENT6W9PS8B71J3
TalcINACTIVE INGREDIENT7SEV7J4R1U3
TocopherolINACTIVE INGREDIENTR0ZB2556P83
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E3
WaterINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-72158892-721-65
58892-72258892-722-65
58892-72358892-723-65

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 96 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 340 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Polysorbate 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
TalcTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
Sorbitan MonolaurateSORBITAN MONOLAURATE6W9PS8B71JTABLET, FILM COATED / ORAL800 mgExact identifier — unii candidate
12 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
TocopherolTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8TABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
TalcTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Ferrosoferric OxideFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
.BETA.-CaroteneBETA CAROTENE01YAE03M7JCREAM / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
Sorbitan MonolaurateSORBITAN MONOLAURATE6W9PS8B71JCAPSULE / ORAL0.08 mgExact identifier — unii candidate
12 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RSOLUTION / RECTALNAExact identifier — unii candidate
9 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSYSTEM / TOPICAL0.04 mgExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b79bd3375f-3df4-4ecc-9185-0157aa0a19dd2013-01-14WarningsExact identifier
spl id: eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7
spl set id: 9bd3375f-3df4-4ecc-9185-0157aa0a19dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.