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 299 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5407 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialtiesf3f86164-2a2e-4f1f-a562-c1ff6cf503222024-07-10WarningsExact identifier
application number: M020
LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.1bbf3712-b59d-cf6d-e063-6294a90af9b72024-07-09WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd1cbcf8a6-0e83-f759-e063-6394a90ac14d2024-07-08WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
application number: M020
HEB BROAD SPECTRUM SPF 30 BANANA SCENTED SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Ba5f02688-cb8a-4d9b-e053-2995a90ad1ba2024-07-08WarningsExact identifier
application number: M020
HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Ba5ef831e-7c28-7c85-e053-2995a90a9e022024-07-08WarningsExact identifier
application number: M020
Equaline Sport Continuous Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENESUPERVALU INC.1cc23322-2570-75ab-e063-6394a90ad2892024-07-08WarningsExact identifier
application number: M020
Equaline Zinc Oxide Sunscreen Stick SPF 50ZINC OXIDEUnited Natural Foods, Inc. dba UNFI1cc27f99-82f3-7aee-e063-6294a90a6f372024-07-08WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.19a8f5d5-d3c7-4a6f-e063-6294a90a94e32024-07-02WarningsExact identifier
application number: M020
All Good Coconut SPF 20 Zinc Oxide Lip BalmZINC OXIDEElemental Herbs, Inc.fdf17ffa-681b-2809-e053-6394a90a5b6e2024-07-02WarningsExact identifier
application number: M020
Sun Shield Soft Glow Daily Face SPF30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEKoco Life LLC1c312800-4068-399e-e063-6394a90aec022024-07-01WarningsExact identifier
application number: M020
Sun on the Run KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c351485-0998-e308-e063-6394a90a9ee62024-07-01WarningsExact identifier
application number: M020
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEBiocosmetica Exel Argentina SRLb2965aba-fcde-16f6-e053-2995a90aa9d82024-06-30WarningsExact identifier
application number: M020
Sun Shield On-the-Glow Sheer Stick SPF40AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c237d5a-1663-e9a1-e063-6294a90a6a242024-06-30WarningsExact identifier
application number: M020
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
application number: M020
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEExelencia Importers, Corp.b2d35086-748b-55d0-e053-2995a90a18982024-06-30WarningsExact identifier
application number: M020
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
application number: M020
Sun Shield Body Glow SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEKoco Life LLC180aa4d5-6dac-e658-e063-6394a90a32872024-06-28WarningsExact identifier
application number: M020
Rose Gold Sun Shield Body Glow SPF45AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1bf7d147-7051-2e76-e063-6294a90a1d132024-06-28WarningsExact identifier
application number: M020
Golden Amber Sun Shield Body Glow SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC1bf97569-024a-9ef1-e063-6394a90a28222024-06-28WarningsExact 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