FDA.reportPublic FDA data

goPure Sunscreen

Product NDC
83448-025
11-digit product format
834480025
Labeler code
83448
Product ID
83448-025_937c741d-6498-4df3-a385-c4866eb3e8b4
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Natural Lifestyle Brands, LLC dba GoPure beauty
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-28
Substance
ZINC OXIDE
Active strength
25 g/100mL
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
goPure Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE25 g/100mL

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
a74ec20b-8436-4030-820c-01fd88134f40Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83448-025-15goPure Sunscreen1 in 1 CARTONLOTION14
83448-025-15goPure Sunscreen15 mL in 1 TUBELOTION154
83448-025-50goPure Sunscreen1 in 1 CARTONLOTION14
83448-025-50goPure Sunscreen50 mL in 1 TUBELOTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83448-025GOPURE SUNSCREEN (ZINC OXIDE) LOTION [NATURAL LIFESTYLE BRANDS, LLC DBA GOPURE BEAUTY]3Current NDC, 4 package rows20241226_a74ec20b-8436-4030-820c-01fd88134f40.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 234 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
natural lip balm SPF15(unflavored) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.2c5a460a-dc93-14cc-e063-6294a90a0b612025-01-23WarningsExact identifier
application number: M020
360 by QUR Lemon Verbena lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb14c2-9181-5970-e053-2a95a90a41612025-01-23WarningsExact identifier
application number: M020
Soleo Organics SunscreenZINC OXIDESE Operations Pty Ltd59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b2025-01-22WarningsExact identifier
application number: M020
Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENeptune Ave. Inc.25034563-6420-daf6-e063-6394a90af9802025-01-22WarningsExact identifier
application number: M020
Jafra Sun body protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e49dd6-305c-f717-e053-2995a90a659c2025-01-22WarningsExact identifier
application number: M020
Jafra Royal Defy Sample KitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3b265b1-ab84-4ea9-b283-c92f5a4cf4612025-01-22WarningsExact identifier
application number: M020
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODYAVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.2c4eaf2e-b034-8185-e063-6394a90a82752025-01-22WarningsExact identifier
application number: M020
Herbalife SKIN Protective Moisturizer Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDEHerbalife International of America Inc.d30b7cf1-73bb-3568-e053-2995a90ad5792025-01-21WarningsExact identifier
application number: M020
Herbalife Herbal Aloe Face and Body Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEHerbalife International of America, Inc.d30d9d02-bc31-db3c-e053-2a95a90a0dab2025-01-21WarningsExact identifier
application number: M020
Sugargirl Disco Stick SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC36f30834-62be-4076-9493-f385720a1e222025-01-20WarningsExact identifier
application number: M020
Sugargirl Glowy Face Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONEI World LLC757897b0-fc65-4147-8444-2a0efdc6f81c2025-01-20WarningsExact identifier
application number: M020
Sugargirl Hot Body Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OCTISALATEI World LLCa9bf1342-1c4b-48ad-a955-715647df125a2025-01-20WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Glow SerumZINC OXIDEBaxter Laboratories Pty. Ltd.2c2c9b67-9588-efbe-e063-6294a90aa6a42025-01-20WarningsExact identifier
application number: M020
JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.Vf627ab5b-85d4-4c92-9412-4bab72828f3d2025-01-17WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
application number: M020
Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50MINERAL SUNSCREENThe Center Brands, LLCcd35ae20-d5b7-479d-8a5e-0278eae9e83c2025-01-17WarningsExact identifier
application number: M020
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83448-025-15834480025151 TUBE in 1 CARTON (83448-025-15) / 15 mL in 1 TUBE1 tube2024-02-16NoNoCurrent
83448-025-50834480025501 TUBE in 1 CARTON (83448-025-50) / 50 mL in 1 TUBE1 tube2023-08-28NoNoCurrent