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 236 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc50182-30f5-b77e-e063-6394a90a63552025-01-15WarningsExact identifier
application number: M020
MEDIFORDEAR CICA CALMING SUNSCREENHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONEYoungwon Costech Co.,ltd.2bc94923-b221-5159-e063-6394a90ab8ff2025-01-15WarningsExact identifier
application number: M020
Meaningful Beauty Cindy Crawford Anti-Aging Day Creme with Environmental Protection Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONEMeaningful Beauty, LLC6423e1c7-85cd-46f8-8fc9-a7284e3577d12025-01-15WarningsExact identifier
application number: M020
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESpectrum Aesthetics Laser Training LLC026b9b30-ef08-bf2e-e063-6394a90a54a62025-01-14WarningsExact identifier
application number: M020
Daily Sunscreen Broad Spectrum SPF 30 UVA UVBMINERAL SUNSCREEN SPF 30IHerb, LLC2d8101ef-96a3-1463-e063-6294a90add4d2025-01-14WarningsExact identifier
application number: M020
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d85b0a1-3705-2829-e063-6394a90a0ed72025-01-13WarningsExact identifier
application number: M020
Attitude mineral sunscreen orange blossom SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0b85ea68-6113-4e92-a10a-39d13099d12d2025-01-13WarningsExact identifier
application number: M020
Skinfuse Shield SPF 30ZINC OXIDEOwen Biosciences, Inc.02d46d44-2476-4f96-9c72-783c392317de2025-01-13Exact identifier
application number: M020
Chem Free SPF 30ZINC OXIDEOwen Biosciences, Inc.7e5930fe-eb0f-4a21-8065-8831dd5b351c2025-01-13WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ShellZINC OXIDEEVER FAME PTE. LTD.2b9b5a73-858e-78dd-e063-6394a90ad0822025-01-13WarningsExact identifier
application number: M020
Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2b9acb63-b32c-336c-e063-6394a90a4a9c2025-01-13WarningsExact identifier
application number: M020
Brush and Go All Skin typesTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd9ee5b3c2-4369-4c4b-ab55-b52661b821882025-01-13WarningsExact identifier
application number: M020
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Inc5c4219ac-d65f-43a5-8ec4-8732b9b344cf2025-01-13WarningsExact identifier
application number: M020
Brush and Go Oily Problematic SkinTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdb4295453-f193-4bed-be5b-efcd917721072025-01-13WarningsExact identifier
application number: M020
Zealios SPF LipGuardOCTISALATE AND AVOBENZONEPersonal Best Products Inc. dba Zealios3a07822b-a7c9-40af-a8f7-bea591c7a49b2025-01-13WarningsExact identifier
application number: M020
SPF-30 BBZINC OXIDEZION HEALTH66d33d8c-8900-4698-98fe-0dedafe674d82025-01-13WarningsExact identifier
application number: M020
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
application number: M020
Skin Apeel Ageless Defense SPF 40 Broad SpectrumZINC OXIDESkin Apeel, Inc.c3bbe779-b012-4f19-8b90-2c7a4dd886172025-01-13WarningsExact identifier
application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEKATE SOMERVILLE SKINCARE LLC1a33cb41-440a-41cb-9832-24255bfa2b7c2025-01-12WarningsExact identifier
application number: M020
ALLSWELL MINERAL SUNSCREEN SPF 30ZINC OXIDEStream2Sea, LLC03bee988-d6e3-4290-a926-9c5366649cba2025-01-12WarningsExact 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