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 90 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTEROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION0a214b6b-69a7-4cb9-9095-6fcf2b6945de2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION207e2035-5f31-4745-a801-b386b040b7382026-01-05WarningsExact identifier
application number: M020
Hawaiian Blend Essential Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group47aa8605-e536-b998-e063-6394a90ad9f02026-01-05WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1OCTINOXATESHISEIDO AMERICAS CORPORATION8a9294c2-3933-4f9c-b7e6-1f446f441a162026-01-05WarningsExact identifier
application number: M020
Shiseido Future Solution LX Total ProtectiveAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION6de17911-4bce-46c9-906b-07d899a36ceb2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc4028089-677f-4d51-9c8b-3892ff1649e02026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION8a0da327-a805-4ef9-b69a-14bf7278a81a2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE CORRECTING VEIL nENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfd9b42e4-6f9d-45a9-bee3-ac1bc4b352522026-01-05WarningsExact identifier
application number: M020
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONb2b55a7a-1f68-429d-ba70-5bb6c7e0d8d32026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMYZINC OXIDEKao USA Inc.26bcb9cd-bfb5-998c-e063-6394a90ab9d62026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUDZINC OXIDEKao USA Inc.26cf1320-aae5-2ea0-e063-6394a90a3be22026-01-05WarningsExact identifier
application number: M020
OZE SUN BONDIZINC OXIDE SUNSCREENVEGANIC SKN LIMITED47b1aae6-0b86-7d48-e063-6294a90a9ece2026-01-05WarningsExact identifier
application number: M020
Hybrid SPF SPF 30OCTOCRYLENE, OCTISALATE, ZINC OXIDETopiderm, Inc.5c99f98c-025c-4886-824f-af968033baf42026-01-05WarningsExact identifier
application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
application number: M020
VEAKSON BEEF TALLOW SUNSCREENZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACIDGuangdong Aimu Biological Technology Co., Ltd473c241a-1258-1680-e063-6394a90a7d982026-01-04WarningsExact identifier
application number: M020
HYDRATING SUNSCREENHYDRATING SUNSCREENGuangzhou Yapeng Refinement Chemical Co., Ltd.19a3687b-32b0-7c83-e063-6294a90aaf812026-01-04WarningsExact identifier
application number: M020
Bellas Friends Sunscreen StickZINC OXIDEPanergytek Usa Inc478cbdeb-28e4-fa56-e063-6294a90af1242026-01-04WarningsExact 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