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 23 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Sequin Supreme SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEGrace and Fire USA Inc.41027faa-7d61-4970-e063-6294a90a7df42026-06-01WarningsExact identifier
application number: M020
Ultra Violette Preen Screen Broad Spectrum SPF 50AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.26a0fc0d-a903-2ac1-e063-6394a90a13db2026-06-01WarningsExact identifier
application number: M020
Timesavvy Hybrid XL Cushion Sun Serum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEProBetter USA, Inc.82a22071-f1bd-4fab-b929-8a00ef18f0d92026-05-31WarningsExact identifier
application number: M020
Marine Screen Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEOSEA International, LLC9aa20377-0ab9-4205-b9aa-24640a4641e72026-05-29WarningsExact identifier
application number: M020
Ciele Blush and Protect SugarZINC OXIDECiele LLC52f3a9f6-a226-6723-e063-6394a90a87062026-05-29WarningsExact identifier
application number: M020
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC52f818f4-8485-b228-e063-6294a90a9fe32026-05-29WarningsExact identifier
application number: M020
Dr.G BRIGHT TONING UP TINTED SUNSCREENZINC OXIDE, OCTISALATE, HOMOSALATEGOWOONSESANG COSMETICS CO., LTD.30d34459-b7fb-b0c6-e063-6294a90a08ac2026-05-28WarningsExact identifier
application number: M020
Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREENZINC OXIDEGOWOONSESANG COSMETICS CO., LTD.30d49f24-3e13-385f-e063-6294a90ab5c82026-05-28WarningsExact identifier
application number: M020
Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREENHOMOSALATE, OCTISALATE, AVOBENZONEGOWOONSESANG COSMETICS CO., LTD.30d53b8a-7e35-0b2b-e063-6294a90aa8df2026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect BerriZINC OXIDECiele LLC52e16cbc-b452-db18-e063-6394a90a40812026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect JuneZINC OXIDECiele LLC52e1c504-f0ee-2853-e063-6394a90a31392026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect JanuaryZINC OXIDECiele LLC52e186df-06aa-6528-e063-6294a90a38882026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect BerriZINC OXIDECiele LLC52e1398d-b170-ea89-e063-6294a90a7d242026-05-28WarningsExact identifier
application number: M020
TIZO ULTRA NON TINTED MINERAL SUNSCREENZINC OXIDE 20%Fallien Cosmeceuticals, LTD30d30610-2e6c-418c-bbcf-4ecd7f61be932026-05-28WarningsExact identifier
application number: M020
Creme FoundationZINC OXIDELauren Brooke Cosmetiques LLC4d09907e-ddcd-9d62-e063-6394a90acf3f2026-05-28WarningsExact identifier
application number: M020
GOONGBE Moisture Sun Cushion Mild SPF 50ZINC OXIDEZero to Seven Inc.1e8720b4-5e8b-dc8b-e063-6394a90aad342026-05-27WarningsExact identifier
application number: M020
GOONGBE Fresh Sun Stick Mild SPF 50ZINC OXIDEZero to Seven Inc.1e8727a4-0dc0-19dc-e063-6394a90a82b62026-05-27WarningsExact identifier
application number: M020
Tallow and Sol SUNSCREEN SPF30NON-NANO ZINC OXIDE 20%Guangzhou Shengyanghui Industrial Trading Co., Ltd52c9dc0a-41f7-3e8a-e063-6394a90a8fca2026-05-27WarningsExact identifier
application number: M020
Tallow and SolSUNSCREEN SPF50NON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd52cb56cf-f092-9f86-e063-6394a90ac2d32026-05-27WarningsExact 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