FDA.reportPublic FDA data

Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide Sunscreen

Product NDC
85638-009
11-digit product format
856380009
Labeler code
85638
Product ID
85638-009_3db1bc66-e64e-3259-e063-6394a90a4770
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
GNL BRANDS INTERNATIONAL, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-04
Substance
ZINC OXIDE
Active strength
206 mg/mL
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
Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE206 mg/mL

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
3db1cf3e-0640-6821-e063-6294a90a7036Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85638-009-66Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide Sunscreen100 mL in 1 TUBELOTION1001

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 121 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Facial Mineral FusionTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC35944621-e6fb-cd98-e063-6294a90aa6412025-12-15Exact identifier
application number: M020
Face LoveZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d043a7-7269-469f-e063-6294a90a1a4d2025-12-15Exact identifier
application number: M020
Mineral MousseTITANIUM DIOXIDE, ZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d00778-3857-ce8f-e063-6394a90ab3752025-12-15Exact identifier
application number: M020
Chem-Free Sunscreen Non-Tinted FormulaZINC OXIDEIT INTELLIGENT TREATMENT LLC3594d573-c680-62c9-e063-6294a90a42292025-12-15Exact identifier
application number: M020
Chem Free Sunscreen Tinted FormulaZINC OXIDEIT INTELLIGENT TREATMENT LLC35948531-37ef-1fce-e063-6294a90ae79b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.35933039-8beb-9f98-e063-6394a90a60bb2025-12-15Exact identifier
application number: M020
Simply Protected Tinted Mineral SunscreenZINC OXIDEHealthy Skin & Body LLC380416b9-180a-3904-e063-6294a90a7bee2025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.3592edca-cab0-6c44-e063-6294a90a17272025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38046e71-f171-7e96-e063-6294a90a1f0b2025-12-15Exact identifier
application number: M020
Barrier Plus Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38038beb-d0f0-ced2-e063-6294a90ac4232025-12-15Exact identifier
application number: M020
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC3764cbeb-55f5-4a9c-e063-6394a90a863d2025-12-15Exact identifier
application number: M020
Happy Mineral Sunscreen Primer SPFTITANIUM DIOXIDE, ZINC OXIDEACNE CLINIC LAS VEGAS BY JUSTINA37d9c5f2-f414-6efa-e063-6294a90a927f2025-12-15Exact identifier
application number: M020
Comfort Mineral Mousse SunscreenTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC3765dd17-ffbd-bcf4-e063-6394a90a2c2b2025-12-15Exact identifier
application number: M020
Prime And Protect DewyZINC OXIDEKalon Skin Studio, LLC3593cefe-a08f-eb88-e063-6394a90aaff62025-12-15Exact identifier
application number: M020
GlowZINC OXIDEGODDESSLYNNEBODYANDSKIN37247365-33ee-563d-e063-6394a90a249e2025-12-15Exact identifier
application number: M020
Prime And Protect MatteTITANIUM DIOXIDE, ZINC OXIDEKalon Skin Studio, LLC35939630-1166-1c70-e063-6294a90aac6b2025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36d9d83b-7da5-a006-e063-6394a90a9d842025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36da1a55-c076-cdd9-e063-6294a90ac97c2025-12-15Exact identifier
application number: M020
Tinted Lip BalmTITANIUM DIOXIDE, ZINC OXIDEGoldberg, Howard S MD Inc3598205d-2e87-9292-e063-6294a90a1f2a2025-12-15Exact identifier
application number: M020
Tinted Daily Replenishing ProtectionZINC OXIDEGoldberg, Howard S MD Inc3597dccf-07a1-5cd9-e063-6294a90aca712025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85638-009-6685638000966100 mL in 1 TUBE (85638-009-66) 100 ml2025-02-04NoNoCurrent