FDA.reportPublic FDA data

Sheer Protection SPF 30

Product NDC
83657-610
11-digit product format
836570610
Labeler code
83657
Product ID
83657-610_471e4ae2-62c6-2ec3-e063-6394a90ac882
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Skin Script, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-01
Substance
ZINC OXIDE
Active strength
.0135 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage83657-61083657-610-08DDiscontinued by firm2026-10-23

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
Sheer Protection SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.0135 g/g

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
0450dcc9-3f8f-e2c2-e063-6294a90af60bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83657-610-03Sheer Protection SPF 3060 g in 1 TUBECREAM604
83657-610-08Sheer Protection SPF 307.5 g in 1 JARCREAM7.54
83657-610-63Sheer Protection SPF 307 g in 1 TUBECREAM74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83657-610SHEER PROTECTION SPF 30 (ZINC OXIDE) CREAM [SKIN SCRIPT, LLC]3Current NDC, 3 package rows20250101_0450dcc9-3f8f-e2c2-e063-6294a90af60b.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 26 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alleyoop Sun Serum Lip Oil - WhirlwindZINC OXIDENewAlley Innovations Inc52be633a-fc64-7456-e063-6294a90a8fc02026-05-26WarningsExact identifier
application number: M020
DRMTLGY Lip Silk - BoldZINC OXIDEDRMTLGY52be6cdf-9ee5-6ce5-e063-6294a90a60752026-05-26WarningsExact identifier
application number: M020
DRMTLGY Lip Silk - SoftZINC OXIDEDRMTLGY52be975c-6a2a-cf21-e063-6294a90a7c1d2026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - GlowZINC OXIDEColorescience52bf01e8-0b4a-5985-e063-6294a90a62c02026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - SavannaZINC OXIDEColorescience52bebdba-6387-cc66-e063-6394a90aa35d2026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Violet HazeZINC OXIDEColorescience52befadc-636f-22bc-e063-6394a90acd182026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Pink SkyZINC OXIDEColorescience52bf204a-ce4e-6e01-e063-6394a90aa9762026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Golden HourZINC OXIDEColorescience52bf2d73-81ad-d455-e063-6294a90a917c2026-05-26WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop Cherry NoirZINC OXIDEBlack Girl Sunscreen5290839a-c84b-b0ec-e063-6394a90abec72026-05-24WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop French KissZINC OXIDEBlack Girl Sunscreen52909e40-1450-250f-e063-6294a90a8a902026-05-24WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop Red WineZINC OXIDEBlack Girl Sunscreen52910220-75f6-23d5-e063-6394a90a9ff32026-05-24WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PopsicleZINC OXIDERiversol529ba685-b4db-37fb-e063-6294a90a54be2026-05-24WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield ImpactZINC OXIDEMental Skin52856524-69d3-90ae-e063-6394a90abc852026-05-23WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield InspireZINC OXIDEMental Skin52854049-ddc2-2d61-e063-6294a90aa22b2026-05-23WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield IntentZINC OXIDEMental Skin52856573-d3c0-55b9-e063-6294a90a1b092026-05-23WarningsExact identifier
application number: M020
Sport UltraAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGuangzhou Danting Bath&Body Care Industry Co. Ltd5268de18-65dc-4253-e063-6394a90a6d4f2026-05-22WarningsExact identifier
application number: M020
Freaks of Nature Daily Defender Broad Spectrum SPF 30FREAKS OF NATURE DAILY DEFENDER BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.5252e628-9db9-110d-e063-6394a90a8e1d2026-05-21WarningsExact identifier
application number: M020
Hampton Sun SPF 30AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 %S&C Hampton Sun LLCeae99a09-9d9e-459d-af96-aef95a854f942026-05-21Exact identifier
application number: M020
Sunforgettable Total Protection Color Balm (Bronze)ZINC OXIDEColorescience9f303e48-037b-6a48-e053-2a95a90a7cf12026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm (Berry)ZINC OXIDEColorescience9f2edb30-b3d6-23dc-e053-2995a90a03dc2026-05-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83657-610-038365706100360 g in 1 TUBE (83657-610-03) 60 g2023-09-01NoNoCurrent
83657-610-08836570610087.5 g in 1 JAR7.5 gHistorical
83657-610-63836570610637 g in 1 TUBE (83657-610-63) 7 g2023-09-01NoNoCurrent