FDA.reportPublic FDA data

Sun Bad

Product NDC
58443-0571
11-digit product format
584430571
Labeler code
58443
Product ID
58443-0571_e81a3ff9-87ea-afed-e053-2995a90a2427
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-07-13
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
42 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 157 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alba Botanica Sensitive Mineral SPF 50ZINC OXIDEThe Hain Celestial Group, Inc.4484b16f-f29a-60cc-e063-6294a90a2b9d2025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF50ZINC OXIDEThe Hain Celestial Group, Inc.0cf9c4b9-8e85-980c-e063-6394a90a9e7e2025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sensitive Mineral SPF 30ZINC OXIDEThe Hain Celestial Group, Inc.44867882-d9c1-7389-e063-6294a90a7f772025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF30ZINC OXIDEThe Hain Celestial Group, Inc.0cf9361f-f292-6429-e063-6294a90add0e2025-11-26WarningsExact identifier
application number: M020
ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.ec8386f2-9cb7-40f4-e053-2995a90ac2d82025-11-26WarningsExact identifier
application number: M020
WOODSLEEP Tallow SunscreenTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.330a9f2e-7ce1-f83f-e063-6394a90a184a2025-11-26WarningsExact identifier
application number: M020
WOODSLEEP Tallow SunscreenTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.33cdde09-e7ee-e003-e063-6394a90a87622025-11-26WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company44718c3c-b081-bcfb-e063-6394a90a37862025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4472cc1e-6b34-388b-e063-6394a90ac7b62025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4472ef69-8992-fcab-e063-6294a90a6b902025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company44732f89-8ac3-8c5d-e063-6394a90aba732025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company447347d6-b8a3-7338-e063-6294a90abbf92025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4473c4cc-f8b5-4a92-e063-6394a90ae6902025-11-25WarningsExact identifier
application number: M020
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
application number: M020
Safe Sea SPF 50 MineralZINC OXIDENidaria Technology Ltd.f6cf9454-552b-486e-a38b-ab3c183b24a12025-11-24WarningsExact identifier
application number: M020
Safe Sea SPF 30ZINC OXIDENidaria Technology Ltd.91bf07ed-0be4-43c9-b5f3-4e8eb892bca52025-11-24WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company5904baa8-3070-1d77-e053-2a91aa0a68522025-11-24WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
application number: M020
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact identifier
application number: M020
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDEKingdom Animalia, LLC DBA Hourglass Cosmetics28e23498-953f-47c0-838c-bbf0e858d9032025-11-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0571-35844305710388 mL in 1 TUBE (58443-0571-3) 88 ml2022-07-130000-00-00NoNoCurrent