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.
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.
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...
DRUG FACTS
Octinoxate 6%
Octocrylene 7%
Oxybenzone 4%
Titanium Dioxide 10%
Zinc Oxide 3.4%
Sunscreen
Sunscreen
Sunscreen
Sunscreen
Sunscreen
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.
For external use only.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product, keep out of eyes. Rinse with water to remove.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
SHAKE WELL BEFORE USING
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:
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.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58892-721-65 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d7e7-cd31-e053-dbdaa90ab51a | 9bd3375f-3df4-4ecc-9185-0157aa0a19dd |
| 58892-722-65 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d7e7-cd31-e053-dbdaa90ab51a | 9bd3375f-3df4-4ecc-9185-0157aa0a19dd |
| 58892-723-65 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d7e7-cd31-e053-dbdaa90ab51a | 9bd3375f-3df4-4ecc-9185-0157aa0a19dd |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-721-65 | Solar Protection Formula SPF 60 Tinted Concealer - (Beige) Sunscreen | 59 mL in 1 BOTTLE | LOTION | 59 | 3 | |
| 58892-721-65 | Solar Protection Formula SPF 60 Tinted Concealer - (Beige) Sunscreen | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 58892-722-65 | Solar Protection Formula SPF 60 Tinted Concealer - (Honey) Sunscreen | 59 mL in 1 BOTTLE | LOTION | 59 | 3 | |
| 58892-722-65 | Solar Protection Formula SPF 60 Tinted Concealer - (Honey) Sunscreen | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 58892-723-65 | Solar Protection Formula SPF 60 Tinted Concealer - (Blush) Sunscreen | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 58892-723-65 | Solar Protection Formula SPF 60 Tinted Concealer - (Blush) Sunscreen | 59 mL in 1 BOTTLE | LOTION | 59 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-721 | 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 [FALLIEN COSMECEUTICALS, LTD.] | 3 | Legacy NDC, 2 package rows | 20130116_9bd3375f-3df4-4ecc-9185-0157aa0a19dd.zip |
| 58892-722 | 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 [FALLIEN COSMECEUTICALS, LTD.] | 3 | Legacy NDC, 2 package rows | 20130116_9bd3375f-3df4-4ecc-9185-0157aa0a19dd.zip |
| 58892-723 | 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 [FALLIEN COSMECEUTICALS, LTD.] | 3 | Legacy NDC, 2 package rows | 20130116_9bd3375f-3df4-4ecc-9185-0157aa0a19dd.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 3 | |
| Octocrylene | ACTIVE INGREDIENT | 5A68WGF6WM | 3 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 3 | |
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 3 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 3 | |
| Octocrylene | ACTIVE MOIETY | 5A68WGF6WM | 3 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 3 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 3 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 3 | |
| .Alpha.-Tocopherol Acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 3 | |
| .BETA.-Carotene | INACTIVE INGREDIENT | 01YAE03M7J | 3 | |
| Alkyl (C12-15) Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 3 | |
| Aluminum Starch Octenylsuccinate | INACTIVE INGREDIENT | I9PJ0O6294 | 3 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | 3 | |
| Butylparaben | INACTIVE INGREDIENT | 3QPI1U3FV8 | 3 | |
| Caramel | INACTIVE INGREDIENT | T9D99G2B1R | 3 | |
| Cetearyl Glucoside | INACTIVE INGREDIENT | 09FUA47KNA | 3 | |
| Cetostearyl Alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 3 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 3 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 3 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| Ferric Oxide Yellow | INACTIVE INGREDIENT | EX438O2MRT | 3 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | 3 | |
| Isobutylparaben | INACTIVE INGREDIENT | 0QQJ25X58G | 3 | |
| Isopropylparaben | INACTIVE INGREDIENT | A6EOX47QK0 | 3 | |
| Linoleamidopropyl Dimethylamine | INACTIVE INGREDIENT | W142CF4WLF | 3 | |
| Maritime Pine | INACTIVE INGREDIENT | 50JZ5Z98QY | 3 | |
| Octyldodecyl Neopentanoate | INACTIVE INGREDIENT | X8725R883T | 3 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 3 | |
| Polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 3 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 3 | |
| Sorbitan Monolaurate | INACTIVE INGREDIENT | 6W9PS8B71J | 3 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 3 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 3 | |
| Triethoxycaprylylsilane | INACTIVE INGREDIENT | LDC331P08E | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58892-721 | 58892-721-65 |
| 58892-722 | 58892-722-65 |
| 58892-723 | 58892-723-65 |
Every source-derived ingredient row is available through these pages.
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| Talc | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| Sorbitan Monolaurate | SORBITAN MONOLAURATE | 6W9PS8B71J | TABLET, FILM COATED / ORAL | 800 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| Talc | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| Ferrosoferric Oxide | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | GEL / TOPICAL | 5 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| .BETA.-Carotene | BETA CAROTENE | 01YAE03M7J | CREAM / TOPICAL | NA | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, EXTENDED RELEASE / ORAL | 4.2 mg | ||
| Sorbitan Monolaurate | SORBITAN MONOLAURATE | 6W9PS8B71J | CAPSULE / ORAL | 0.08 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAVENOUS | 30 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / RECTAL | 0.01 %w/v | ||
| Caramel | CARAMEL | T9D99G2B1R | SOLUTION / RECTAL | NA | ||
| Ascorbyl Palmitate | ASCORBYL PALMITATE | QN83US2B0N | SYSTEM / TOPICAL | 0.04 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRA-ARTICULAR | 0.05 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| Caramel | CARAMEL | T9D99G2B1R | SUSPENSION / ORAL | 111.12 mg/5ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SUSPENSION / ORAL | 80 mg | ||
| Cetostearyl Alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | OINTMENT / TOPICAL | 1.2 %w/w | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAMUSCULAR | 1.62 %w/v | ||
| Ascorbyl Palmitate | ASCORBYL PALMITATE | QN83US2B0N | SOLUTION / TOPICAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SPRAY, METERED / NASAL | 40 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SPRAY / NASAL | 1 mg | ||
| Cetostearyl Alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | SPRAY / TOPICAL | 1 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| Ferric Oxide Yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SUPPOSITORY / VAGINAL | NA | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| .Alpha.-Tocopherol Acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7 | 9bd3375f-3df4-4ecc-9185-0157aa0a19dd | 2013-01-14 | Warnings | eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7 9bd3375f-3df4-4ecc-9185-0157aa0a19dd |
Adverse event summaries are temporarily unavailable. Other product information remains available.