FDA.reportPublic FDA data

EltaMD UV Clear SPF46

Product NDC
72043-2500
11-digit product format
720432500
Labeler code
72043
Product ID
72043-2500_e1ccd02f-6246-493f-8ce5-a39b29b7bde7
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide and Octinoxate sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
CP Skin Health Group, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-10
Substance
ZINC OXIDE; OCTINOXATE
Active strength
90; 75 g/1000g; g/1000g
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
EltaMD UV Clear SPF46
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE90 g/1000g
OCTINOXATE75 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
60438ec5-0b1f-45fd-8ce4-debfdbdc6721Available 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72043-2500-1EltaMD UV Clear SPF4648 g in 1 BOTTLELOTION489
72043-2500-2EltaMD UV Clear SPF462 g in 1 PACKETLOTION29
72043-2500-3EltaMD UV Clear SPF46106 g in 1 TUBELOTION1069
72043-2500-5EltaMD UV Clear SPF4614 g in 1 BOTTLELOTION149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72043-2500ELTAMD UV CLEAR SPF46 (ZINC OXIDE AND OCTINOXATE SUNSCREEN) LOTION [CP SKIN HEALTH GROUP, INC.]8Current NDC, Legacy NDC, 4 package rows20250503_60438ec5-0b1f-45fd-8ce4-debfdbdc6721.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 8 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceile tint PROTECT tinted serum SPF 50 IvoryCEILE TINT PROTECT TINTED SERUM SPF 50 IVORYLE COSMETICS INC58547809-3480-1032-e063-6294a90a04c62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium DeepCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEPLE COSMETICS INC58549160-3594-9056-e063-6394a90abf7d2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 DeepCEILE TINT PROTECT TINTED SERUM SPF 50 DEEPLE COSMETICS INC585498d4-b29c-9580-e063-6394a90adf1e2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 FairCEILE TINT PROTECT TINTED SERUM SPF 50 FAIRLE COSMETICS INC58545633-cb36-6611-e063-6394a90a1f072026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 LightCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHTLE COSMETICS INC5853ae6b-0eaf-e614-e063-6394a90ae91a2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light MediumCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUMLE COSMETICS INC585473c3-3ee9-7d84-e063-6394a90abd332026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 MediumCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUMLE COSMETICS INC58547b48-251a-10eb-e063-6294a90ac95c2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium TanCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TANLE COSMETICS INC58547e38-ae84-82ee-e063-6394a90a27d62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 TanCEILE TINT PROTECT TINTED SERUM SPF 50 TANLE COSMETICS INC58548331-38cd-8668-e063-6394a90a33622026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium HoneyCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEYLE COSMETICS INC5854861a-376d-8825-e063-6394a90a8aab2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 HoneyCEILE TINT PROTECT TINTED SERUM SPF 50 HONEYLE COSMETICS INC585488c5-fac5-212f-e063-6294a90a00ff2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium RichCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICHLE COSMETICS INC585488af-d14f-8d71-e063-6394a90ac4f02026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 RichCEILE TINT PROTECT TINTED SERUM SPF 50 RICHLE COSMETICS INC58548e6d-9c82-249c-e063-6294a90a11ad2026-08-05WarningsExact identifier
application number: M020
12 Days of Derm-Loved SkincareOCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENERodan & Fieldsa13f0275-5add-4464-88d4-ff98232743252026-08-03WarningsExact identifier
application number: M020
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
application number: M020
Manyo Air Light Moisturizing Sunscreen SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENEManyo Factory Corp.86761577-a32c-41a2-a2e3-b339b14937012026-08-03WarningsExact identifier
application number: M020
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
application number: M020
AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30OCTISALATE, OCTOCRYLENE, AVOBENZONEAMBI Enterprises LLC99bbe9a2-bb57-4a33-b339-1649d4b319c82026-07-31WarningsExact identifier
application number: M020
AMBI Even and Clear Facial Moisturizer SPF-30AVOBENZONE, OCTISALATE, OCTOCRYLENEAMBI Enterprises LLC4701c0ba-4ceb-4d66-9f99-515ce33b46482026-07-31WarningsExact identifier
application number: M020
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72043-2500-17204325000148 g in 1 BOTTLE (72043-2500-1) 48 g2018-01-100000-00-00NoNoCurrent
72043-2500-2720432500022 g in 1 PACKET (72043-2500-2) 2 g2022-07-060000-00-00NoNoCurrent
72043-2500-372043250003106 g in 1 TUBE (72043-2500-3) 106 g2025-06-04NoNoCurrent
72043-2500-57204325000514 g in 1 BOTTLE (72043-2500-5) 14 g2020-12-170000-00-00NoNoCurrent