FDA.reportPublic FDA data

GUIDANCE TO GLOW TRU SPF 35

Product NDC
84444-506
11-digit product format
844440506
Labeler code
84444
Product ID
84444-506_1bb558bf-848a-1991-e063-6394a90a03d8
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
GUIDANCE TO GLOW SKIN CARE
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-12
Substance
ZINC OXIDE
Active strength
120 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
GUIDANCE TO GLOW TRU SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE120 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
21b4747b-b173-43c9-b0d4-1dbba5775ff8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84444-506-00GUIDANCE TO GLOW TRU SPF 3550 mL in 1 TUBECREAM501
84444-506-00GUIDANCE TO GLOW TRU SPF 351 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84444-506GUIDANCE TO GLOW TRU SPF 35 (ZINC OXIDE) CREAM [GUIDANCE TO GLOW SKIN CARE]1Current NDC, 2 package rows20240627_21b4747b-b173-43c9-b0d4-1dbba5775ff8.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 111 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Covergirl Clean Fresh Blurring Skintint SPF 30 Mineral Sunscreen Liquid Foundation- All shadesZINC OXIDENoxell3fa58ac5-f45c-369a-e063-6294a90a46e42025-12-17WarningsExact identifier
application number: M020
Ray Defense Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements807db1ff-a64a-44e4-a786-f88cd45184332025-12-17WarningsExact identifier
application number: M020
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements, Inc981c7b3c-d7d6-483d-bf32-10d526be5b3f2025-12-17WarningsExact identifier
application number: M020
Glow Oil SPF 50 Beach FlowerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2a46d7d2-293f-5024-e063-6294a90a31aa2025-12-17WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Inc0f114022-daaa-1834-e063-6394a90afd1d2025-12-17WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Inc0f113048-adfb-7d2a-e063-6294a90a20122025-12-17WarningsExact identifier
application number: M020
Coppertone Oil Free and Shine Control Face Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incf3d163b4-6774-4c2e-e053-2a95a90afd592025-12-17WarningsExact identifier
application number: M020
Coppertone EveryTone Face Sunscreen SPF 55AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b12f39-778c-ecee-e063-6394a90afa242025-12-17WarningsExact identifier
application number: M020
Skin On Skin BC Foundation SPF 40 - Fair CoolOCTISALATE, HOMOSALATE, ZINC OXIDEYENSA Beauty, LLC462e9a4a-ef28-0e0e-e063-6394a90ab4f82025-12-17WarningsExact identifier
application number: M020
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
application number: M020
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact identifier
application number: M020
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
application number: M020
Avail Body with SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEEmeis Cosmetics Pty Ltd4bb39ea1-f948-4357-b425-0cafd454ce302025-12-17WarningsExact identifier
application number: M020
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
application number: M020
Miffy Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd98a2906d-61e2-4627-a695-a20f10872f9a2025-12-16WarningsExact identifier
application number: M020
Dear Sun Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd80748647-e0ea-46dc-8ee2-a0ad77c4b19d2025-12-16WarningsExact identifier
application number: M020
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
application number: M020
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATESupergoop LLCdb12a89f-5fef-1b2a-e053-2a95a90a56f92025-12-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84444-506-00844440506001 TUBE in 1 BOX (84444-506-00) / 50 mL in 1 TUBE1 tube2024-06-12NoNoCurrent