FDA.reportPublic FDA data

Scalp and Face Sunscreen

Product NDC
87598-101
11-digit product format
875980101
Labeler code
87598
Product ID
87598-101_551bee10-9884-17f0-e063-6294a90ac7fa
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Only Balds LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-25
Substance
ZINC OXIDE
Active strength
10 g/100mL
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
Scalp and Face Sunscreen
Brand name suffix
Broad Spectrum SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE10 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
551bf10e-598c-1400-e063-6294a90a4af1Available on FDA.report

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 232 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Shimmer One Mineral Glow SPF 45ZINC OXIDEKao USA Inc.0c935521-4e8b-0605-e063-6394a90a0bbc2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7ce5b9-5ab4-d845-e063-6394a90afa762025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Mineral One Lightweight Serum SPF 50ZINC OXIDEKao USA Inc.0c91894f-a40e-73e9-e063-6394a90ab8072025-01-31WarningsExact identifier
application number: M020
Hello Sunday The One Thats a Serum Hydrating Serum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c913096-c000-4336-e063-6394a90a560c2025-01-31WarningsExact identifier
application number: M020
Hello Sunday Bestseller Daily SPF DuoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.26cf264b-f68d-5691-e063-6394a90a8ab42025-01-31WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d0856cf-d3da-5a77-e063-6294a90ad5b42025-01-31WarningsExact identifier
application number: M020
FRE PROTECT BODY Ultra-Light Gel Cream SPF 50ZINC OXIDEPeer Pharm Ltd.2cd83c55-851c-089e-e063-6294a90ad6bc2025-01-30WarningsExact identifier
application number: M020
FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50ZINC OXIDEPeer Pharm Ltd.2cd958a3-bad6-725e-e063-6294a90a85782025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30ZINC OXIDEPeer Pharm Ltd.2cd77d62-77df-f3a9-e063-6394a90ad57d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30ZINC OXIDEPeer Pharm Ltd.2caf3b6b-3a05-b24a-e063-6394a90a47992025-01-30WarningsExact identifier
application number: M020
Jil Goorman Skincare Sun Guard SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY9a088bed-3b85-4bf5-923b-4c99eb904a8d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30ZINC OXIDEPeer Pharm Ltd.2baf0278-7e13-4db0-e063-6294a90ae9de2025-01-30WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.08a175ae-2307-ef8d-e063-6394a90ad2342025-01-30WarningsExact identifier
application number: M020
Babo Botanicals Super Shield Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc08b7bcfd-0c7c-a14f-e063-6294a90a77972025-01-30WarningsExact identifier
application number: M020
Salt and Stone Sunscreen Lip Balm SPF 30ZINC OXIDESalt and Stone LLCb555aa10-1547-63cc-e053-2995a90ad20d2025-01-30WarningsExact identifier
application number: M020
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
application number: M020
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87598-101-11875980101111 BOTTLE, PUMP in 1 CARTON (87598-101-11) / 50 mL in 1 BOTTLE, PUMP2026-06-25NoNoCurrent
87598-101-12875980101121 BOTTLE, PUMP in 1 CARTON (87598-101-12) / 115 mL in 1 BOTTLE, PUMP2026-06-25NoNoCurrent