FDA.reportPublic FDA data

Ware Sonny Universal

Product NDC
83510-400
11-digit product format
835100400
Labeler code
83510
Product ID
83510-400_43906087-7f16-b1d1-e063-6294a90a7395
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Ware Cosmetics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-08
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
9.7; 19.4 mg/mL; mg/mL
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
Ware Sonny Universal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE9.7 mg/mL
TITANIUM DIOXIDE19.4 mg/mL

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
fe2b9d16-9215-e21e-e053-6394a90a5156Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83510-400-01Ware Sonny Universal30 mL in 1 BOTTLE, PUMPLOTION304
83510-400-02Ware Sonny Universal1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83510-400WARE SONNY UNIVERSAL (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WARE COSMETICS]2Current NDC, 2 package rows20241009_fe2b9d16-9215-e21e-e053-6394a90a5156.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 116 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0c1ca-80a8-9d37-e063-6294a90a824f2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0f5df-6bfb-3c0d-e063-6294a90a2e5f2025-12-16Exact identifier
application number: M020
Daily Protect Mineral SunscreenZINC OXIDESARAH'S4617beb7-381e-8994-e063-6394a90a14b52025-12-16WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENTENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDEShiseido Americas Corporation8db9f5e0-a8d6-4872-b4c6-cb92c43d25c22025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation18ed9b7f-bdbe-45d7-a38c-6d065080ae992025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE FOR BODY NENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationa2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c2025-12-16WarningsExact identifier
application number: M020
b.tan Beach Please SPF 7AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarque of Brands Americas, LLCbdc07d83-a34f-5262-e053-2995a90acfc32025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S461910bd-1f74-f99e-e063-6394a90ae30e2025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S4619b08f-3e63-25aa-e063-6294a90a78d72025-12-16WarningsExact identifier
application number: M020
megALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48Meg Cosmetics Inc4526bacf-6451-b297-e063-6294a90af71a2025-12-16WarningsExact identifier
application number: M020
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
application number: M020
Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32ZINC OXIDEOnekind.25c11197f4-cee0-04b3-e053-2995a90a1ba82025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Medium DeepZINC OXIDECrunchi, LLC.69618265-2ebb-4cdc-a28f-e36c07fe5b8f2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 MediumZINC OXIDECrunchi, LLC.23248bc3-1b82-443a-b38a-df7f0efb5d2a2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 LightZINC OXIDECrunchi, LLC.cf4039f5-00ee-4227-a3dc-61995c8001352025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Body Sunscreen SPF 30ZINC OXIDECrunchi, LLC.227f5a41-8c3c-492d-947f-e2b046208bca2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Light MediumZINC OXIDECrunchi, LLC.5b3f2766-065b-4817-a5ff-bd1c7882bfc92025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Daily Facial Sunscreen SPF 30ZINC OXIDECruchi, LLC.4f3bcfa0-e43e-4284-afaa-6488ddd749f02025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543a22c-34d5-e572-e063-6394a90ad5792025-12-15Exact identifier
application number: M020
Stellar Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6488c-d216-8742-e063-6394a90a16e22025-12-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83510-400-018351004000130 mL in 1 BOTTLE, PUMP30 mlHistorical
83510-400-02835100400021 BOTTLE, PUMP in 1 CARTON (83510-400-02) / 30 mL in 1 BOTTLE, PUMP (83510-400-01) 2023-05-08NoNoCurrent