Isa SunGuard SPF 30

Product NDC
76187-850
11-digit product format
761870850
Labeler code
76187
Product ID
76187-850_0c5b86f1-c352-510a-e063-6394a90a0b56
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Isagenix International, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-26
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
60; 23 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct76187-850EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76187-85076187-850-03EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Isa SunGuard SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE60 mg/mL
TITANIUM DIOXIDE23 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
abe1e345-6ea2-43b3-8613-b5b5e04c87b7Available on FDA.report

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
TITANIUMACTIVE MOIETYD1JT611TNEISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
ALLANTOININACTIVE INGREDIENT344S277G0ZISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
DIETHYLHEXYL CARBONATEINACTIVE INGREDIENTYCD50O0Z6LISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1EISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC]2

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

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 23 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Preen Screen Broad Spectrum SPF 50AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.26a0fc0d-a903-2ac1-e063-6394a90a13db2026-06-01WarningsExact identifier
application number: M020
Timesavvy Hybrid XL Cushion Sun Serum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEProBetter USA, Inc.82a22071-f1bd-4fab-b929-8a00ef18f0d92026-05-31WarningsExact identifier
application number: M020
Marine Screen Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEOSEA International, LLC9aa20377-0ab9-4205-b9aa-24640a4641e72026-05-29WarningsExact identifier
application number: M020
Ciele Blush and Protect SugarZINC OXIDECiele LLC52f3a9f6-a226-6723-e063-6394a90a87062026-05-29WarningsExact identifier
application number: M020
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC52f818f4-8485-b228-e063-6294a90a9fe32026-05-29WarningsExact identifier
application number: M020
Dr.G BRIGHT TONING UP TINTED SUNSCREENZINC OXIDE, OCTISALATE, HOMOSALATEGOWOONSESANG COSMETICS CO., LTD.30d34459-b7fb-b0c6-e063-6294a90a08ac2026-05-28WarningsExact identifier
application number: M020
Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREENZINC OXIDEGOWOONSESANG COSMETICS CO., LTD.30d49f24-3e13-385f-e063-6294a90ab5c82026-05-28WarningsExact identifier
application number: M020
Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREENHOMOSALATE, OCTISALATE, AVOBENZONEGOWOONSESANG COSMETICS CO., LTD.30d53b8a-7e35-0b2b-e063-6294a90aa8df2026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect BerriZINC OXIDECiele LLC52e16cbc-b452-db18-e063-6394a90a40812026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect JuneZINC OXIDECiele LLC52e1c504-f0ee-2853-e063-6394a90a31392026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect JanuaryZINC OXIDECiele LLC52e186df-06aa-6528-e063-6294a90a38882026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect BerriZINC OXIDECiele LLC52e1398d-b170-ea89-e063-6294a90a7d242026-05-28WarningsExact identifier
application number: M020
TIZO ULTRA NON TINTED MINERAL SUNSCREENZINC OXIDE 20%Fallien Cosmeceuticals, LTD30d30610-2e6c-418c-bbcf-4ecd7f61be932026-05-28WarningsExact identifier
application number: M020
Creme FoundationZINC OXIDELauren Brooke Cosmetiques LLC4d09907e-ddcd-9d62-e063-6394a90acf3f2026-05-28WarningsExact identifier
application number: M020
GOONGBE Moisture Sun Cushion Mild SPF 50ZINC OXIDEZero to Seven Inc.1e8720b4-5e8b-dc8b-e063-6394a90aad342026-05-27WarningsExact identifier
application number: M020
GOONGBE Fresh Sun Stick Mild SPF 50ZINC OXIDEZero to Seven Inc.1e8727a4-0dc0-19dc-e063-6394a90a82b62026-05-27WarningsExact identifier
application number: M020
Tallow and Sol SUNSCREEN SPF30NON-NANO ZINC OXIDE 20%Guangzhou Shengyanghui Industrial Trading Co., Ltd52c9dc0a-41f7-3e8a-e063-6394a90a8fca2026-05-27WarningsExact identifier
application number: M020
Tallow and SolSUNSCREEN SPF50NON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd52cb56cf-f092-9f86-e063-6394a90ac2d32026-05-27WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen Face and BodyZINC OXIDEToddle Born Wild, Inc.e97d82fe-cd45-43a5-9c1f-3900025240a12026-05-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76187-850-03761870850031 TUBE in 1 PACKAGE (76187-850-03) / 100 mL in 1 TUBE1 tube2017-12-190000-00-00NoNoCurrent