Florida Glow face shield SPF 55

Product NDC
83862-004
11-digit product format
838620004
Labeler code
83862
Product ID
83862-004_5d2c512b-4510-20d1-e063-6294a90a1416
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octocrylene, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Southeast Holdings Corp.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-19
Substance
HOMOSALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
10; 5; 5.8 g/100mL; g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Florida Glow face shield SPF 55
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE10 g/100mL
OCTOCRYLENE5 g/100mL
ZINC OXIDE5.8 g/100mL

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
83862-004-01Florida Glow face shield SPF 5570 mL in 1 BOTTLELOTION703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83862-004FLORIDA GLOW FACE SHIELD SPF 55 (HOMOSALATE, OCTOCRYLENE, ZINC OXIDE) LOTION [SOUTHEAST HOLDINGS CORP.]1Current NDC, 1 package rows20250502_cea54600-5308-4b9f-98ca-fef0b26d79c1.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 81 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Botao Baby Mineral Sunscreen LZINC OXIDEPeer Pharm Ltd.e1564df9-90cb-0b1f-e053-2a95a90acb5e2026-01-12WarningsExact identifier
application number: M020
FRE GLOW ME SPF 50 Lightweight Tinted Moisturizer Medium DeepZINC OXIDEPeer Pharm Ltd1d4559e7-91d4-6c85-e063-6394a90af8952026-01-12WarningsExact identifier
application number: M020
Sun and Shine - Mineral Sunscreen Clear Facial Stick SPF 50ZINC OXIDEPeer Pharm Ltd.20755fd4-ad05-4de2-84f5-fb29c0c5b1042026-01-12WarningsExact identifier
application number: M020
Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 50ZINC OXIDEPeer Pharm Ltd.75763dc1-c762-42fc-a8fe-4d9d7bde0ce62026-01-12WarningsExact identifier
application number: M020
SUN and SHINE MINERAL SUNSCREENZINC OXIDEPeer Pharm Ltd.897eb75c-d7d6-4fce-afdd-f794fd8a82fd2026-01-12WarningsExact identifier
application number: M020
LINOZINC OXIDELino Cosmetics LLC262ef129-9453-2411-e063-6294a90ae2232026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50ZINC OXIDECrown Laboratoriesbb101039-dd3c-46da-e053-2a95a90aff8b2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50ZINC OXIDECrown Laboratoriesbfefb252-7e37-4675-e053-2995a90acb932026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50ZINC OXIDECrown Laboratoriesbfefb36b-0858-6e4d-e053-2a95a90a01ce2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories9d20b230-2cce-4d90-e053-2995a90a4c032026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDECrown Laboratoriesc20fce25-8120-fe5d-e053-2a95a90a53a02026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesbaed8202-21fd-3a43-e053-2a95a90ada322026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECrown Laboratories88dbd396-8955-271e-e053-2995a90a0a7a2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories9d237fb7-4f5f-521d-e053-2a95a90a97342026-01-12WarningsExact identifier
application number: M020
PanOxyl Oil AM Control MoisturizerZINC OXIDECrown Laboratoriesf7e33151-e9a6-dae0-e053-6394a90a99952026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories1e4d49f4-9e77-48b5-bce5-ff04ed885a0f2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d6e04a-fa30-ba48-e063-6394a90a1bbf2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f780daa-4c91-5a68-e063-6394a90afd412026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50ZINC OXIDECrown Laboratories99839894-9695-2cd1-e053-2995a90acba62026-01-12WarningsExact identifier
application number: M020
Blue Lizard SPF 15 Lip BalmZINC OXIDECrown Laboratories1bf8fb7e-9d5b-86d4-e063-6294a90afddc2026-01-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83862-004-018386200040170 mL in 1 BOTTLE (83862-004-01) 70 ml2021-01-19NoNoCurrent