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 70 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields7fe05ef6-dd5f-4f25-bbf7-24f9396427072026-01-23WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen NacreCEILE SPF 30 PRIME PROTECT RADIATE NACRELE COSMETICS INC4915de09-3a2c-cb75-e063-6394a90a6a572026-01-23WarningsExact identifier
application number: M020
SPF 50 Sunscreen StickZINC OXIDEAustralian Gold248d761c-2120-4019-9463-9952bc367e732026-01-23WarningsExact identifier
application number: M020
SOLBAR THIRTYSUNSCREENPerson and Covey48ed3be8-d146-ec2c-e063-6394a90a6c4d2026-01-22WarningsExact identifier
application number: M020
MISSHA ALL AROUND ESSENCE SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f557b5-a844-8c94-e063-6394a90af2202026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW DEWY HDRATING SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f5e9ab-38e0-f12c-e063-6294a90aab8b2026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREENZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDEAble C&C Co., Ltd.48f6361d-d738-62df-e063-6294a90aaac52026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 35 AVOSUNSCREENPerson and Covey4a5692d5-0835-d18f-e063-6394a90a29292026-01-22WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF15OCTINOXATE, AVOBENZONE, OCTISALATEDongguan Taimeng Accessories Co., Ltd.48f70710-7960-5fa5-e063-6394a90a4ce62026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 ZINCSUNSCREENPerson and Covey48fc01dd-0be4-5c63-e063-6294a90a23622026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 SHIELDSUNSCREENPerson and Covey48fcd463-8ce4-1e78-e063-6394a90a98e72026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 50 FIFTYSUNSCREENPerson and Covey48fef521-1b24-d0d5-e063-6394a90ac7b12026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 110HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7456f4bb-d0ec-439d-b807-d00b4c01c1112026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 121HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.2dd51960-515f-4502-b261-5e5d5f57e0912026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 140HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5b835716-af13-4e23-bdae-d391864acb6f2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 132HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa258570-ee21-423d-bad6-010d14792a862026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 212HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa84c1b5-a9b6-408e-b9fd-0dadebaf374e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 221HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6b7a016c-c3b1-4f90-80c9-fe47c52916492026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 151HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5d029d93-7f3d-4624-bcd7-40df9230414e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 232HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f724d68-3c6e-4b95-894e-78b2da220a302026-01-22WarningsExact 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