FDA.reportPublic FDA data

GOONGBE Waterful SunLotion Mild SPF 40

Product NDC
43319-072
11-digit product format
433190072
Labeler code
43319
Product ID
43319-072_52d6846e-8348-2adf-e063-6394a90a5f18
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Zero to Seven Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
ZINC OXIDE
Active strength
17.82 g/100g
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
GOONGBE Waterful SunLotion Mild SPF 40
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17.82 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
1e86edfd-d089-ba41-e063-6294a90a6709Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43319-072-11GOONGBE Waterful SunLotion Mild SPF 4080 g in 1 BOTTLE, PLASTICLOTION803
43319-072-11GOONGBE Waterful SunLotion Mild SPF 401 in 1 BOXLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43319-072GOONGBE WATERFUL SUNLOTION MILD SPF 40 (ZINC OXIDE) LOTION [ZERO TO SEVEN INC.]2Current NDC, 2 package rows20250101_1e86edfd-d089-ba41-e063-6294a90a6709.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 284 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30ZINC OXIDETOPCO ASSOCIATES LLCf71e019b-392a-f8eb-e053-6394a90a871e2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCa5b06600-f2b0-6d9b-e053-2995a90a59f02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultra Protection Sun SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf41d4c46-7998-afe6-e053-2995a90ab3612024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50OCTISALATE, ZINC OXIDETOPCO ASSOCIATES LLCf71c9060-3daf-e1be-e053-6294a90a4f912024-10-15WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Mineral Sunscreen StickZINC OXIDEH.E.B.f58f0199-bf22-2197-e053-2995a90ae64f2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry ScentedZINC OXIDEH.E.B.f58d328c-8b30-b4d4-e053-2a95a90adb592024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape ScentedZINC OXIDEH.E.B.f58ed2f9-67c3-ce91-e053-2995a90a12292024-10-15WarningsExact identifier
application number: M020
HEB Shimmer Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5930029-4c96-2576-e053-2995a90a7bed2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Birthday Cake SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5a3313e-4935-1ce3-e053-2a95a90a6ad12024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b6caf2-ebff-79fb-e053-2995a90ac2f82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 For Men SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf59461e3-9521-6a7b-e053-2a95a90a73b82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2c266-6fc9-21ae-e053-2995a90aec0e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b7172a-b8fc-0d11-e053-2a95a90a9f732024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Peach Bellini Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cbac04-361f-9226-e053-2995a90a2d7b2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Cucumber Water Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5d933cf-3461-8b03-e053-2a95a90ad79f2024-10-15WarningsExact identifier
application number: M020
HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.Bf6ce4ea0-d92f-368c-e053-6294a90a2a812024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2702c-5451-58a1-e053-2a95a90adb8e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Strawberry Daquiri Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cb5f9a-6691-37c3-e053-2a95a90a9af02024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Rosewater Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5db7ec6-0e9b-7044-e053-2a95a90a1e482024-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43319-072-11433190072111 BOTTLE, PLASTIC in 1 BOX (43319-072-11) / 80 g in 1 BOTTLE, PLASTIC2025-01-01NoNoCurrent