FDA.reportPublic FDA data

TINTED WATERY SUNSCREEN

Product NDC
87487-100
11-digit product format
874870100
Labeler code
87487
Product ID
87487-100_4ced53d0-8bfd-ff8e-e063-6294a90a9dbd
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
KSISTERS PTE. LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-13
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
4.22; 4.9 g/100mL; g/100mL
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
TINTED WATERY SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE4.22 g/100mL
ZINC OXIDE4.9 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
4ced53d0-8bfc-ff8e-e063-6294a90a9dbdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87487-100-01TINTED WATERY SUNSCREEN50 mL in 1 TUBELOTION501
87487-100-02TINTED WATERY 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 149 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen tintedTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3000a0a7-2b51-b832-e063-6294a90a4a082025-12-08WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001028b-bb36-04ec-e063-6294a90a1e492025-12-08WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001aa3a-cc8b-6ad4-e063-6394a90a223f2025-12-08WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC300268ff-f9ef-1006-e063-6294a90a5fdf2025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF 40 Lightly TintedZINC OXIDEFace 5, LLC3001ef4f-4cbb-8931-e063-6394a90a5cef2025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF40 Non-TintedZINC OXIDEFace 5, LLC300218c9-65cf-d984-e063-6294a90a15172025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF 40 Lightly TintedZINC OXIDEFace 5, LLC300303e7-ef89-7449-e063-6294a90ac8112025-12-08WarningsExact identifier
application number: M020
Clear Path Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDELULUS SPA BOUTIQUE37657755-fa82-88a0-e063-6394a90ade472025-12-08Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare376468ce-8d9b-b672-e063-6294a90a0bd12025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
application number: M020
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
application number: M020
Protect Mineral Stick ClearTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bfa392-dfec-bd8a-e063-6394a90acffa2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b9d646-e049-6781-e063-6294a90ab1012025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen Non-TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be70d5-aefe-fd6f-e063-6394a90ac4362025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be17ce-c3a7-fd59-e063-6394a90ad11d2025-12-08Exact identifier
application number: M020
Protect Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35c044a6-90be-55f8-e063-6294a90aad482025-12-08Exact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUMOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ed877-2926-1fd9-e063-6394a90aa1532025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87487-100-018748701000150 mL in 1 TUBE50 mlHistorical
87487-100-02874870100021 TUBE in 1 BOX (87487-100-02) / 50 mL in 1 TUBE (87487-100-01) 1 tube2026-03-13NoNoCurrent