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 331 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0f32e-4b19-7a62-e063-6394a90af1b12023-10-30WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe5e5777c-2f67-14ed-e053-2a95a90a58a52023-10-30WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc08fb4748-d22d-35af-e063-6394a90a08272023-10-30WarningsExact identifier
application number: M020
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.d177b085-2bbd-49c1-b02b-a7b8d8ee04682023-10-28WarningsExact identifier
application number: M020
Live Tinted Hueguard 3-in1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.cfceaf45-bab5-6858-e053-2a95a90a6be12023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Hueguard Invisible Sunscreen Stick Broad Spectrum SPF 50 Water Resistant 80 MinsHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELive Tinted, Inc.8e4d7c84-5acb-4857-860d-bf6837e4901e2023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.7bceeb0e-b557-438c-88ac-0148f6eb1b4d2023-10-28WarningsExact identifier
application number: M020
Green Defense daily mineral sunscreen Broad Spectrum SPF 30ZINC OXIDEFarmacy Beauty LLCd1ae2696-fd1b-4422-a8e0-5209aeeb97eb2023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Glow-up Hyperpigmentation EssentialsZINC OXIDELive Tinted, Inc.ef06c1eb-6ce3-4b1b-8a7d-3e29ae1728442023-10-28WarningsExact identifier
application number: M020
SPF Elio Drops 30 SheerZINC OXIDEAllure Labs Inc08c9fc56-7d4f-ebc5-e063-6294a90a53172023-10-28WarningsExact identifier
application number: M020
SPF Elio Drops 30 GlowZINC OXIDEAllure Labs Inc08cbf8d6-8c27-1567-e063-6394a90a932e2023-10-28WarningsExact identifier
application number: M020
RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skinAVOBENZONE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCd1ca8372-28a0-41e1-b92a-913fc09f71562023-10-27WarningsExact identifier
application number: M020
Vivier Sheer SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.1be5ee36-3566-495c-aae2-4d0d7fc210ed2023-10-27WarningsExact identifier
application number: M020
Vivier Sheer SPF 45ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATEVivier Pharma, Inc.c057138a-1111-4e7c-b94d-2ccd6bc3963c2023-10-27WarningsExact identifier
application number: M020
360 by QUR Spanish lime lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb3347-7498-3d7a-e053-2995a90a4b122023-10-26WarningsExact identifier
application number: M020
360 by QUR Vanilla lace lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb4c53-adaa-3a8a-e053-2a95a90ae93a2023-10-26WarningsExact identifier
application number: M020
360 by QUR Watercress mint lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb7413-c074-a2d7-e053-2a95a90ac5cb2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-cherry vanillaHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCc827c6b4-c6d7-4585-b615-419db9520e7c2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-citrusHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLC2f20ee7e-3897-4263-b965-5155d89bfb5e2023-10-26WarningsExact 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