FDA.reportPublic FDA data

Isa SunGuard SPF 30

Manufacturer
Isagenix International, LLC | Englewood Lab, Inc.
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:04:45

Label at a glance#

ProductIsa SunGuard SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure19 sections

Indications and uses

Helps prevent sunburn Higher SPF gives more sunburn protection

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                        Purpose Zinc Oxide 6.0%.......................................Sunscreen Titanium Dioxide 2.3%..............................Sunscreen

OTC - PURPOSE SECTION

Uses   Helps prevent sunburn   Higher SPF gives more sunburn protection

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Higher SPF gives more sunburn protection

WARNINGS SECTION

Warnings  For External use only

OTC - DO NOT USE SECTION

Do not use on irritated or broken skin

OTC - STOP USE SECTION

Stop use and ask a physician if rash, irritation or sensitivity develops and lasts.

OTC - WHEN USING SECTION

When using this product do not ger into eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions  -  Apply liberally before sun exposure to the sun.  -  Reapply after excessive perspiration or swimming.  -  Ask a doctor before use on children under 3 years of age.

PRECAUTIONS SECTION

Other information  Sun alert:  Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

INACTIVE INGREDIENT SECTION

Inactive Ingredients  Water (Aqua/Eau), Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Polysorbate 80, Caprylyl Methicone, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Diethylhexyl Carbonate, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Panthenol, Allantoin, Disodium EDTA, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethoxysilyllethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Glycerin, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Algae Extract, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorophenesin

DESCRIPTION SECTION

Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays.  Manufactured for Isagenix International LLC,  Distributed by Isagenix International LLC AZ 85286 USA.  Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada  3900949.000-00  Item #40040

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Reveal a New You  REJUVITY   REJUVITY  ISAGENIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Isa SunGuard All-natural  SPF 30 Featuring Zinc Oxide and Titanium Dioxide  3.4 OZ (100 ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REJUVITY  ISAGENIX  Isa SunGuard  All-natural  SPF 30 Featuring Zinc Oxide and Titanium Dioxide  3.4 OZ (100 ml)   Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays.   Manufactured for Isagenix International LLC,  Distributed by Isagenix International LLC AZ 85286 USA.  Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada  3901021.000-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Isa 1Isa 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Isa 2Isa 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Isa 3Isa 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76187-850-03Isa SunGuard SPF 30100 mL in 1 TUBECREAM1009
76187-850-03Isa SunGuard SPF 301 in 1 PACKAGECREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76187-850ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]9Current NDC, Legacy NDC, 2 package rows20231217_abe1e345-6ea2-43b3-8613-b5b5e04c87b7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
TITANIUMACTIVE MOIETYD1JT611TNE2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
ALLANTOININACTIVE INGREDIENT344S277G0Z2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69332
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z2
DIETHYLHEXYL CARBONATEINACTIVE INGREDIENTYCD50O0Z6L2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933092
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76187-85076187-850-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
CYCLOMETHICONENMQ347994ZIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
POLYSORBATE 806OZP39ZG8HIACT
ISOHEXADECANE918X1OUF1EIACT
CETYL ALCOHOL936JST6JCNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIETHYLHEXYL CARBONATEYCD50O0Z6LIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHAMOMILEFGL3685T2XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ALUMINUM OXIDELMI26O6933IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 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
Isa SunGuard SPF 30ZINC OXIDE, TITANIUM DIOXIDEIsagenix International, LLCabe1e345-6ea2-43b3-8613-b5b5e04c87b72023-12-12WarningsExact identifier
ndc (package): 76187-850-03
ndc (product): 76187-850
ndc11 (package): 76187085003
spl id: 0c5b86f1-c352-510a-e063-6394a90a0b56
spl set id: abe1e345-6ea2-43b3-8613-b5b5e04c87b7

Reported adverse events (FAERS/openFDA)#

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