FDA.reportPublic FDA data

Sun Guard

Product NDC
70983-024
11-digit product format
709830024
Labeler code
70983
Product ID
70983-024_4851c3b3-b351-8628-e063-6294a90ad4ba
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Saje Natural Business Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-09
Substance
ZINC OXIDE
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Sun Guard
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87ee593d-668c-f592-e053-2a95a90a17b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-024-01Sun Guard100 mL in 1 TUBELOTION1005
70983-024-02Sun Guard180 mL in 1 TUBELOTION1805
70983-024-03Sun Guard50 mL in 1 TUBELOTION505
70983-024-03Sun Guard1 in 1 BOXLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-024SUN GUARD (ZINC OXIDE) LOTION [SAJE NATURAL BUSINESS INC]4Current NDC, Legacy NDC, 4 package rows20231006_87ee593d-668c-f592-e053-2a95a90a17b1.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 328 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. C. Tuna Resurface Essential Day CreamHOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONEFarmasi US LLCb92ff1e9-9dc4-46cb-a99d-98ff15bffc792023-11-05WarningsExact identifier
application number: M020
Dr C Tuna Sun protector lip balm SPF 15HOMOSALATE, OCTINOXATEFarmasi US LLCddcd82b5-9ad2-2340-e053-2a95a90a4fc02023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCdeee5784-c68b-4cd7-acbf-f64391a01bfc2023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLCcef1a926-b7d4-47d6-957d-e3092e60970c2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance Brightening CreamOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCb55790f7-20f2-404e-9a0e-5e76c383bf752023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance Brightening Cream 22 SPFOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCde493e30-d10e-9def-e053-2995a90ae49a2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Face and Body SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC141f9d22-deb7-4b6b-97b5-ee21898b96f72023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 06 DeepTITANIUM DIOXIDEFarmasi US LLC2f13a160-740f-4b09-8858-e438a9ba303e2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Bronzing Oil SPF 6OCTINOXATEFarmasi US LLC91b428cc-1c80-4d56-8450-790c66de41332023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 05 TanTITANIUM DIOXIDEFarmasi US LLC3f494921-844e-4010-ab0c-144c8dce8aca2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25TITANIUM DIOXIDEFarmasi US LLCf4fcfc78-9591-4a20-b9fb-88e1dc9b221d2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLC0d913242-2e57-4ba7-a718-154af68480b22023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 03 MediumTITANIUM DIOXIDEFarmasi US LLC6ef986df-4044-4c32-8b64-f8110c9c95432023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCde24317f-2cf0-4125-bb17-c3d6b3c22e002023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 05 TanTITANIUM DIOXIDEFarmasi US LLC22842793-ae1f-4b71-8db9-34c06dc37daa2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 03 MediumTITANIUM DIOXIDEFarmasi US LLC9f203e7f-3bba-4f36-a35a-6d9466e390822023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 06 DeepTITANIUM DIOXIDEFarmasi US LLCc28afa3b-9a8d-4e19-bc6b-39cc8428c9f92023-11-05WarningsExact identifier
application number: M020
DR. C Tuna Sunscreen 30 SPF Broad Spectrum Face and bodyAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATETAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIa71ee8e0-2d27-7ae6-e053-2a95a90aecd42023-11-05WarningsExact identifier
application number: M020
PHARMACA Natural Mineral Sunscreen SPF-50TITANIUM DIOXIDE, ZINC OXIDEPharmaca Integrative Pharmacy, Inc.51e6cd7a-5c9a-4666-9021-ade42eb064cd2023-11-05WarningsExact identifier
application number: M020
Dr.C.Tuna Sun Face Cream SPF50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketif668c078-61e6-2c81-e053-2a95a90a31002023-11-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-024-0170983002401100 mL in 1 TUBE (70983-024-01) 100 ml2019-05-090000-00-00NoNoCurrent
70983-024-0270983002402180 mL in 1 TUBE (70983-024-02) 180 ml2019-05-090000-00-00NoNoCurrent
70983-024-03709830024031 TUBE in 1 BOX (70983-024-03) / 50 mL in 1 TUBE1 tube2019-06-250000-00-00NoNoCurrent