FDA.reportPublic FDA data

SPF-40 facial moisturizer

Manufacturer
Mineral Fusion brands
Effective date
2013-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:41:05

Label at a glance#

ProductSPF-40 facial moisturizer
Active ingredientZinc Oxide, Titanium dioxide
Label structure11 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply a liberal amount daily before sun exposure. Initial whiteness turns clear after application. Reapply every 2-3 hours to maintain protection.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - PURPOSE SECTION

Provides broad-spectrum protection from the sun's damaging rays while moisturizers and peptides lend anti-aging benefits.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply a liberal amount daily before sun exposure. Initial whiteness turns clear after application. Reapply every 2-3 hours to maintain protection.

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

7.5% Titanium Dioxide, 5.0% Zinc Oxide

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Juice, Capric Caprylic Triglycerides, Ethylhexyl Palmitate, Glyceryl Stearate, Cetyl Dimethicone, Glycerin, Hexyl Laurate, Pollyglyceryl-4 Isostearate, Cetyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea Butter), Panthenol, Magnesium Aspartate, Zinc Gluconate, Copper Gluconate (Copper Peptides), Pamitoyl Pentapeptide-4, Malachite Extract, Smithsonite Extract, Rhodochrosite Extract, Hematite Extract, Tocopherol Acetate, Allantoin, Sodium PCA, Soy Lecithin, Magnesium Aluminum Silicate, Camellia Sinensis (Green Tea) Extract, Sodium Hyaluronate, Calendula Officinalis Flower Extract, Ethylhexylglycerin, Phenoxyethanol

WARNING

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use in or near the eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Mild skin irritation may occur. Stop use and ask a physician if irritation is severe.

OTC - DO NOT USE SECTION

Do not use on infants under 6 months old.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SUNBURN ALERT

SPL UNCLASSIFIED SECTION

Limiting sun exposure, wearing protective clothing, and using a sunscreen agent may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

SPL UNCLASSIFIED SECTION

Distributed By:
glōProfessional
Denver, CO 80223

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSCREEN

glō•therapeutics

SPF 40 Facial
Moisturizer

7.5% Titanium Dioxide,
5% Zinc Oxide,
Peptides

FACIAL SUNSCREEN

Principal Display Panel - 60 mL Tube Carton
Principal Display Panel - 60 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55789-0101-12019-11-27C16284748780-19855d018-d90d-cd31-e053-dbdaa90ab51aSPF-40 facial moisturizer

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55789-0101SPF-40 FACIAL MOISTURIZER (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [MINERAL FUSION BRANDS]1Legacy NDC20130410_5095f202-461d-4008-b6d7-9b73f220f279.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium dioxideACTIVE MOIETY15FIX9V2JP1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
allantoinINACTIVE INGREDIENT344S277G0Z1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
cetyl dimethicone 25INACTIVE INGREDIENTU4AS1BW4ZB1
copper gluconateINACTIVE INGREDIENTRV823G6G671
ethylhexyl palmitateINACTIVE INGREDIENT28659933091
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
green tea leafINACTIVE INGREDIENTW2ZU1RY8B01
hexyl laurateINACTIVE INGREDIENT4CG9F9W01Q1
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4TH1
jojoba oilINACTIVE INGREDIENT724GKU717M1
lecithin, soybeanINACTIVE INGREDIENT1DI56QDM621
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NC1
magnesium aspartateINACTIVE INGREDIENTR17X820ROL1
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7U1
palmitoyl pentapeptide-4INACTIVE INGREDIENTKK181SM5JG1
panthenolINACTIVE INGREDIENTWV9CM0O67Z1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
polyglyceryl-4 isostearateINACTIVE INGREDIENT820DPX33S71
shea butterINACTIVE INGREDIENTK49155WL9Y1
sodium pyrrolidone carboxylateINACTIVE INGREDIENT469OTG57A21
tocopherolINACTIVE INGREDIENTR0ZB2556P81
zinc gluconateINACTIVE INGREDIENTU6WSN5SQ1Z1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55789-010155789-0101-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Titanium dioxide15FIX9V2JPACTIB
ethylhexyl palmitate2865993309IACT
glyceryl monostearate230OU9XXE4IACT
cetyl dimethicone 25U4AS1BW4ZBIACT
glycerinPDC6A3C0OXIACT
hexyl laurate4CG9F9W01QIACT
aloe vera leafZY81Z83H0XIACT
polyglyceryl-4 isostearate820DPX33S7IACT
medium-chain triglyceridesC9H2L21V7UIACT
cetyl alcohol936JST6JCNIACT
shea butterK49155WL9YIACT
panthenolWV9CM0O67ZIACT
magnesium aspartateR17X820ROLIACT
zinc gluconateU6WSN5SQ1ZIACT
jojoba oil724GKU717MIACT
tocopherolR0ZB2556P8IACT
copper gluconateRV823G6G67IACT
hyaluronate sodiumYSE9PPT4THIACT
palmitoyl pentapeptide-4KK181SM5JGIACT
ethylhexylglycerin147D247K3PIACT
allantoin344S277G0ZIACT
sodium pyrrolidone carboxylate469OTG57A2IACT
lecithin, soybean1DI56QDM62IACT
magnesium aluminum silicate6M3P64V0NCIACT
green tea leafW2ZU1RY8B0IACT
phenoxyethanolHIE492ZZ3TIACT

Source Document#

Source XML · Source PDF

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 3 · 177 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
glycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
lecithin, soybeanSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii candidate
7 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
hyaluronate sodiumHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
17 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCONCENTRATE / ORAL410 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / RECTAL14480 mgExact identifier — unii candidate
17 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
lecithin, soybeanSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCGRANULE, FOR SUSPENSION / ORAL12.5 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
hyaluronate sodiumHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAVITREAL23 mgExact identifier — unii candidate
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
hyaluronate sodiumHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAMUSCULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION/ DROPS / ORAL4.15 mg/2.5mlExact identifier — unii candidate
17 equally ranked IID candidates
lecithin, soybeanSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
magnesium aluminum silicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 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
2a3e08c0-663a-4cc6-a9e7-79d1c9f336725095f202-461d-4008-b6d7-9b73f220f2792026-03-16WarningsExact identifier
spl set id: 5095f202-461d-4008-b6d7-9b73f220f279

Reported adverse events (FAERS/openFDA)#

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