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 41 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light Medium ZINC OXIDE ZO Skin Health, Inc. 4fabe9d0-27fe-230f-e063-6294a90a9ac0 2026-04-17 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-Tan ZINC OXIDE ZO Skin Health, Inc. 4fac82b7-d685-2a0d-e063-6394a90aa795 2026-04-17 Warnings Exact identifier application number: M020 SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50 SUNSCREEN Saltair Body LLC 4fae649d-f60e-0275-e063-6294a90a1ea5 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e64-2eab-1219-e063-6294a90a79a8 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cd8a3-3d62-83ac-e063-6394a90a4afa 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e2424f4-0011-42b0-e063-6394a90a780d 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHT YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cfaea-b71f-2956-e063-6294a90a4f20 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316d1515-6092-a7d6-e063-6394a90ab8b2 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e70-6ec3-5711-e063-6394a90a3879 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e241343-db63-3f1c-e063-6394a90ab538 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316df5fe-0574-d59f-e063-6294a90af8b9 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316c5d69-46f4-7677-e063-6294a90a610f 2026-04-17 Warnings Exact identifier application number: M020 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 PML NYC, LLC 316d905f-232c-d8a2-e063-6394a90adbc9 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N PML NYC, LLC 316ea01b-4bff-55be-e063-6394a90add94 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 410 N PML NYC, LLC 316e97bc-4b96-ba6e-e063-6294a90a7648 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c781d7-9d48-892f-e053-2a95a90aca86 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c757b4-6c92-18f0-e053-2a95a90a246d 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c76a82-dc87-35e7-e053-2995a90ae310 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7ac71-3f38-52b2-e053-2a95a90ab54e 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7b929-7492-f072-e053-2995a90a1ca3 2026-04-17 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