FDA.reportPublic FDA data

Mineral Sunscreen

Manufacturer
CA-Botana International
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:42:45

Label at a glance#

ProductMineral Sunscreen
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21%............................................. Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscreen

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Coco-Caprylate/Caprate, Ceteary Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermun parki (Shea butter), Cetearyl Olivate, Sorbitan Olivate, Caaprylhydroxamic acid. GlycerylCaprylate, Glycerin, Xanthan Gum, Equisetum arvense (Horsetail) extract, Rosmarinus officinalis (Rosemary) extract, Centella asiatica(Gotu-kola) extract, Aesculus hippocastanum (Horse chestnut) extract, Camellia sinensis(Green tea) extract, Olea europaea (Olive) extract, Tocopheryl Acetate, Potassium Acetate, Sodium Phytate, Citrus nobilis/Mandarinorage) Peel oil, Coconut oil, Helianthus annuus (Sunflower) Seed oil, Silica, Triethpxycapryylsilane, OXY CA (Rosmarinus officnalis (Leaf)CO2 Extract& Ascorbyl Palmitate & Caprylic/Capric Triglyceride & Ascorbic Acid & Tocopherol & Citric Acid )

Safety information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. 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 of 15 or higher and othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun.

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. If product is swallowed get medical help or contact a poison Control Center right away.

Indications & Usage

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor

PACKAGE LABEL PRINCIPAL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gabriel-Sunscreen-Label.8( 1)Gabriel-Sunscreen-Label.8( 1)

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35192-044-15Mineral Sunscreen61 g in 1 TUBEEMULSION616

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35192-044MINERAL SUNSCREEN (ZINC OXIDE) EMULSION [CA-BOTANA INTERNATIONAL]6Legacy NDC, 1 package rows20241215_28e0ab0f-ab45-d61a-e063-6294a90ac4fc.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35192-04435192-044-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN OLIVATEMDL271E3GRIACT
EQUISETUM ARVENSE WHOLE73DM367W4PIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
SUNFLOWER OIL3W1JG795YIIACT
DIMETHICONOL TRIETHOXYCAPRYLYLSILANE TETRAETHYL SILICATE CROSSPOLYMER (4000000 MW)6CA31A9P15IACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETEARYL OLIVATE58B69Q84JOIACT
ALLANTOIN344S277G0ZIACT
ROSEMARYIJ67X351P9IACT
HEXASODIUM PHYTATEZBX50UG81VIACT
ZINC OXIDESOI2LOH54ZACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT
ETHYL FERULATE5B8915UELWIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERYL CAPRATE197M6VFC1WIACT
CENTELLA ASIATICA7M867G6T1UIACT
GREEN OLIVE6HD2W46UEGIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ORANGE PEELTI9T76XD44IACT
COCOS NUCIFERA WHOLE245J88W96LIACT
HYDRATED SILICAY6O7T4G8P9IACT
ASCORBYL PALMITATEQN83US2B0NIACT
MICAV8A1AW0880IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HORSE CHESTNUT3C18L6RJAZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SHEA BUTTERK49155WL9YIACT

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
29160692-1044-728b-e063-6294a90ab9fb28e0ab0f-ab45-d61a-e063-6294a90ac4fc2024-12-12WarningsExact identifier
spl id: 29160692-1044-728b-e063-6294a90ab9fb
spl set id: 28e0ab0f-ab45-d61a-e063-6294a90ac4fc

Reported adverse events (FAERS/openFDA)#

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