Home NDC 76187-850 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 76187-850 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 76187-850 76187-850-03 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…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 Ingredient Strength ZINC OXIDE 60 mg/mL TITANIUM DIOXIDE 23 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76187-850-03 Isa SunGuard SPF 30 100 mL in 1 TUBE CREAM 100 9 76187-850-03 Isa SunGuard SPF 30 1 in 1 PACKAGE CREAM 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 TITANIUM ACTIVE MOIETY D1JT611TNE ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 CHAMOMILE INACTIVE INGREDIENT FGL3685T2X ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 CYCLOMETHICONE INACTIVE INGREDIENT NMQ347994Z ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 DIETHYLHEXYL CARBONATE INACTIVE INGREDIENT YCD50O0Z6L ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 ETHYLHEXYL PALMITATE INACTIVE INGREDIENT 2865993309 ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 GLYCYRRHIZA GLABRA INACTIVE INGREDIENT 2788Z9758H ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 POLYHYDROXYSTEARIC ACID (2300 MW) INACTIVE INGREDIENT YXH47AOU0F ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76187-850 ISA SUNGUARD SPF 30 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ISAGENIX INTERNATIONAL, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20231217_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 39 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HYDRA SPF 34 HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE Drmtlgy, LLC 31e41ed5-8498-4e2d-928a-c15ca99775e4 2026-04-21 Warnings Exact identifier application number: M020 FORGESKIN MINERAL TALLOW SUNSCREEN GUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD 4fe913f4-b0be-dc53-e063-6294a90a363c 2026-04-20 Warnings Exact identifier application number: M020 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM AVOBENZONE, HOMOSALATE, OCTISALATE SEORIN COMPANY Co., Ltd. 228dcd68-aaba-0451-e063-6394a90a8ad0 2026-04-20 Warnings Exact identifier application number: M020 Biore Aqua Rich UV OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA f900db18-5fe2-1d74-e053-6394a90a3ca2 2026-04-20 Warnings Exact identifier application number: M020 Biore UV Aqua Rich OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA 2bc23bb5-86bb-7915-e063-6394a90a9d72 2026-04-20 Warnings Exact identifier application number: M020 ETUDE SunPrise Mild Airy Finish Sunstick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ETUDE CORPORATION 25abc744-5b62-acb4-e063-6394a90af110 2026-04-19 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b05e-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b060-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7d9f4-986f-70f7-e053-2a95a90a4f8a 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c81845-afcb-18ac-e053-2a95a90abdbe 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c83245-a40c-8f05-e053-2a95a90a0521 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c84047-fd3b-ea66-e053-2a95a90ae9aa 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c623aa-3846-b7f4-e053-2995a90aecb5 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c585ff-88de-e29c-e053-2a95a90af4d4 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c852de-4c36-6d93-e053-2995a90aff61 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c86288-bb22-03b1-e053-2995a90a3161 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8742f-1060-48bc-e053-2995a90a31c2 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c4eedc-12a0-6418-e053-2a95a90a55e7 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8849a-6624-6987-e053-2a95a90a4546 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8ac70-a8c8-2f07-e053-2a95a90a3d01 2026-04-18 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76187-850-03 76187085003 1 TUBE in 1 PACKAGE (76187-850-03) / 100 mL in 1 TUBE 1 tube 2017-12-19 0000-00-00 No No Current