FDA.reportPublic FDA data

Mineral Sunscreen SPF 50

Manufacturer
Better Planet Brands LLC
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:19:14

Label at a glance#

ProductMineral Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

• helps prevent sunburn

Dosage and administration

Directions_• apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating. • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn

Warnings

WARNINGS SECTION

• For external use

OTC - DO NOT USE SECTION

• Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

• When using the product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

• Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children.

If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions_• apply liberally 15 minutes before sun exposure

reapply at least every 2 hours
use a water-resistant sunscreen if swimming or sweating. • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.
May stain some

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF JUICE*, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYESTER-8, GLYCERIN, WATER, CETEARYL ALCOHOL, GLYCERYL STEARATE, SQUALANE, ISOAMYL LAURATE, SORBITAN SESQUIOLEATE, TOCOPHEROL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, HELANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM HYALURONATE, HYDROLYZED JOJOBA ESTERS, BISABOLOL, PULLULAN, SCLEROTIUM GUM, XANTHAN GUM, GLYCOLIPIDS, GLYCERYL CAPRYLATE, SODIUM STEAROYL GLUTAMATE, POLYHYDROXYSTEARIC ACID, COCO-GLUCOSIDE, LYSOLECITHIN, SILICA, CAPRYLHYDROXAMIC ACID, CITRIC ACID

Questions?

OTC - QUESTIONS SECTION

Call toll-free 877.902.2873

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54136-351-92Mineral Sunscreen SPF 5092 g in 1 TUBECREAM924

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54136-35154136-351-92

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
BETASIZOFIRAN2X51AD1X3TIACT
ACENEURAMIC ACIDGZP2782OP0IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
XANTHAN GUMTTV12P4NEEIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
SUNFLOWER OIL3W1JG795YIIACT
HYALURONATE SODIUMYSE9PPT4THIACT
LEVOMENOL24WE03BX2TIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ISOAMYL LAURATEM1SLX00M3MIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
LYSOPHOSPHATIDYLCHOLINE, SOYBEANCQD833204ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
WATER059QF0KO0RIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
PULLULAN8ZQ0AYU1TTIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
COCO-GLUCOSIDEICS790225BIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SQUALANEGW89575KF9IACT
JOJOBA OIL724GKU717MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen SPF 50ZINC OXIDEBetter Planet Brands LLC1d8e727c-8b50-9cf2-e063-6394a90a2e152025-12-03WarningsExact identifier
ndc (package): 54136-351-92
ndc (product): 54136-351
ndc11 (package): 54136035192
spl id: 45132ba3-8152-c77a-e063-6294a90a0868
spl set id: 1d8e727c-8b50-9cf2-e063-6394a90a2e15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.