FDA.reportPublic FDA data

Solar Protection Formula LipTect

Manufacturer
Fallien Cosmeceuticals, LTD. | Custom Analytics LLC | Process Technologies & Packaging
Effective date
2012-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:33:59

Label at a glance#

ProductSolar Protection Formula LipTect Lip Balm/Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 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. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying 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 protecti...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Purpose

OTC - PURPOSE SECTION

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • 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

Other Information:

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxides, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Offinale (Ginger) Root Oil

Manufactured exclusively for: Fallien Cosmeceuticals Ltd., West Norriton, PA 19403

Principal Display Panel – 4.5g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58892-240-45

SOLAR

PROTECTION

FORMULA®

LIPTECT

SPF 45

Broad Spectrum

UVA/UVB

Water Resistant (80 minutes)

Ultra High Sun Protection

No Chemical Sunscreen Filters

.14 oz. Net Wt. (4.5 g)

Principal Display Panel – 4.5g Carton Label
Principal Display Panel – 4.5g Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58892-240-452019-11-27C16284748780-19855d018-e4c2-cd31-e053-dbdaa90ab51a0f43b7c6-5e4e-4458-94e2-314e223f9396

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-240-45Solar Protection Formula LipTect Lip Balm/Sunscreen4.5 g in 1 TUBELIPSTICK4.52
58892-240-45Solar Protection Formula LipTect Lip Balm/Sunscreen1 in 1 CARTONLIPSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-240SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2Legacy NDC, 2 package rows20121218_0f43b7c6-5e4e-4458-94e2-314e223f9396.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP2
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z2
Titanium DioxideACTIVE MOIETY15FIX9V2JP2
Zinc OxideACTIVE MOIETYSOI2LOH54Z2
.ALPHA.-TocopherolINACTIVE INGREDIENTH4N855PNZ12
.ALPHA.-Tocopherol Acetate, D-INACTIVE INGREDIENTA7E6112E4N2
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN02
Aluminum OxideINACTIVE INGREDIENTLMI26O69332
Aluminum StearateINACTIVE INGREDIENTU6XF9NP8HM2
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSL2
Ascorbic AcidINACTIVE INGREDIENTPQ6CK8PD0R2
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0N2
C12-15 Alkyl BenzoateINACTIVE INGREDIENTA9EJ3J61HQ2
CeresinINACTIVE INGREDIENTQ1LS2UJO3A2
Cetearyl IsononanoateINACTIVE INGREDIENTP5O01U99NI2
Ethylhexyl PalmitateINACTIVE INGREDIENT28659933092
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G6752
Ginger OilINACTIVE INGREDIENTSAS9Z1SVUK2
HexyldecanolINACTIVE INGREDIENT151Z7P13172
Hexyldecyl LaurateINACTIVE INGREDIENT0V595C1P6M2
Kiwi FruitINACTIVE INGREDIENT71ES77LGJC2
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM622
Lime (Citrus)INACTIVE INGREDIENT8CZS5469542
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQ2
Propylene Glycol Dicaprylate/DicaprateINACTIVE INGREDIENTO4446S9CRA2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP2
Sunflower OilINACTIVE INGREDIENT3W1JG795YI2

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-24058892-240-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Aluminum OxideLMI26O6933IACT
Aluminum Hydroxide5QB0T2IUN0IACT
Aluminum StearateU6XF9NP8HMIACT
Ascorbic AcidPQ6CK8PD0RIACT
Ascorbyl PalmitateQN83US2B0NIACT
C12-15 Alkyl BenzoateA9EJ3J61HQIACT
CeresinQ1LS2UJO3AIACT
Cetearyl IsononanoateP5O01U99NIIACT
Anhydrous Citric AcidXF417D3PSLIACT
Propylene Glycol Dicaprylate/DicaprateO4446S9CRAIACT
Ethylhexyl Palmitate2865993309IACT
Kiwi Fruit71ES77LGJCIACT
Lime (Citrus)8CZS546954IACT
Sunflower Oil3W1JG795YIIACT
Hexyldecanol151Z7P1317IACT
Hexyldecyl Laurate0V595C1P6MIACT
Ferric Oxide Red1K09F3G675IACT
Lecithin, Soybean1DI56QDM62IACT
Polyethylene Glycol 400B697894SGQIACT
Stearic Acid4ELV7Z65APIACT
.ALPHA.-TocopherolH4N855PNZ1IACT
.ALPHA.-Tocopherol Acetate, D-A7E6112E4NIACT
Ginger OilSAS9Z1SVUKIACT

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 4 · 205 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAMUSCULAR192 mgExact identifier — unii candidate
25 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RTABLET / ORAL80 mgExact identifier — unii candidate
25 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
Aluminum StearateALUMINUM STEARATEU6XF9NP8HMTABLET / ORAL6 mgExact identifier — unii candidate
5 equally ranked IID candidates
Aluminum StearateALUMINUM STEARATEU6XF9NP8HMTABLET, EXTENDED RELEASE / ORAL105 mgExact identifier — unii candidate
5 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii candidate
36 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / TOPICAL11100 mgExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSPONGE / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
CeresinCERESINQ1LS2UJO3ACREAM / VAGINAL280 mgExact identifier — unii candidate
2 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
Aluminum StearateALUMINUM STEARATEU6XF9NP8HMCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
5 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAMUSCULAR20.3 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RCAPSULE, DELAYED RELEASE / ORAL12 mgExact identifier — unii candidate
25 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLFILM / SUBLINGUAL11 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 equally ranked IID candidates
.ALPHA.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii candidate
36 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLLOZENGE / TRANSMUCOSAL44 mgExact identifier — unii candidate
61 equally ranked IID candidates
.ALPHA.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii candidate
36 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
Aluminum StearateALUMINUM STEARATEU6XF9NP8HMCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INFILTRATION0.2 %w/vExact identifier — unii candidate
25 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAMUSCULAR101 mgExact identifier — unii candidate
61 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii candidate
36 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
Aluminum HydroxideALUMINUM HYDROXIDE5QB0T2IUN0CAPSULE / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET / BUCCAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / SUBCUTANEOUS101 mgExact identifier — unii candidate
61 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRACAVITARY5 mgExact identifier — unii candidate
25 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSPRAY, METERED / NASAL320 mgExact identifier — unii candidate
36 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 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
dbea6f0c-95d1-420f-85ff-b97845ca30180f43b7c6-5e4e-4458-94e2-314e223f93962012-12-14WarningsExact identifier
spl id: dbea6f0c-95d1-420f-85ff-b97845ca3018
spl set id: 0f43b7c6-5e4e-4458-94e2-314e223f9396

Reported adverse events (FAERS/openFDA)#

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