FDA.reportPublic FDA data

Reflecting Mineral Sunscreen

Product NDC
85767-610
11-digit product format
857670610
Labeler code
85767
Product ID
85767-610_3750f04b-7fa0-8793-e063-6294a90a9143
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Helande, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-01
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
.135; .023 g/100mL; g/100mL
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
Reflecting Mineral Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.135 g/100mL
TITANIUM DIOXIDE.023 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3750f04b-7f9f-8793-e063-6294a90a9143Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85767-610-01Reflecting Mineral Sunscreen30 mL in 1 BOTTLE, PLASTICLOTION301
85767-610-01Reflecting Mineral Sunscreen1 in 1 BOXLOTION11

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 58 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association6307627a-94e2-47ea-8519-68975716dd6e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationa38e150e-2e50-4936-ae46-408f9cf82d152026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association87811c86-19d2-4179-8d22-2aeb4680ff572026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationd7215a32-00a9-4b70-8597-8ea91f546c1e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association9fccccd4-2d2e-4812-85b1-bbeb44ff04ea2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.be702a3b-1652-4468-803d-295100d3e3e22026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.644ec129-15c9-4ac1-8362-5b4c2e58ab9a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
SPF BeautySPF BEAUTYWalmart Inc.f06f26af-81d6-4603-b377-fd12430ec9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
SPF MoisturizerSPF MOISTURIZERWalmart Inc.41de3171-9ed3-45da-96fb-dfcf419122292026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Facial MoisturizerDAILY FACIAL MOISTURIZER SPF 15Walmart Inc.2cec9c90-2e64-f005-e063-6294a90a87532026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEWalmart Inc.309d881d-40e0-37bc-e063-6294a90a37692026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEWalmart Inc.d3d7a5d3-5c78-45c3-ba4b-7ac1a3b4526a2026-02-27WarningsExact identifier
application number: M020
MELAO Sunscreen StickETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd4ba15c03-0409-918b-e063-6294a90ac6ee2026-02-26WarningsExact identifier
application number: M020
Olay Regenerist Whip Lightweight Moisturizer with Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4bbc0639-3a80-1c28-e063-6394a90a3c002026-02-26WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab66c16-5f4c-6987-e063-6294a90add862026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
Seonglow Daily Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeonGlow Inc.01f3479f-3a0d-420b-bbf8-62a0a225bc9b2026-02-26WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab5d5ca-26bf-1c5f-e063-6394a90a00ca2026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
SPF50 Moisturizer with Aloe, Green Tea and Shea ButterZINC OXIDEAudrey Morris Cosmetics International, LLC92960e14-9845-49aa-b3ce-c8023aa109b62026-02-26WarningsExact identifier
application number: M020
Naturalessa SPF50 MoisturizerZINC OXIDEAudrey Morris Cosmetics International, LLC816ddfa1-cb55-4591-a90b-71631cb176262026-02-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85767-610-01857670610011 BOTTLE, PLASTIC in 1 BOX (85767-610-01) / 30 mL in 1 BOTTLE, PLASTIC2025-07-01NoNoCurrent