8578 SPF 50 Baby Skin Mineral Sunscreen Lotion

Manufacturer
Babo Botanicals, Inc. | Bell International Laboratories
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:29

Label at a glance#

ProductBaby Skin Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Dosage and administration

Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a sunscreen with the approved active ingredient of Zinc Oxide at 20%.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%. Purpose: Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscree

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the 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. • Stop use and ask doctor if rash occurs. • Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTAL-LINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA).*Certified Organic Ingredients

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3 fl oz / 89 mL ml NDC: 79265-8578-3

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8578-3Baby Skin Mineral Sunscreen89 mL in 1 TUBELOTION893

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8578BABY SKIN MINERAL SUNSCREEN (MINERAL SUNSCREEN) LOTION [BABO BOTANICALS, INC.]3Legacy NDC, 1 package rows20241215_b0a4ac6b-8f88-8a9a-e053-2995a90ab10e.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-857879265-8578-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

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
291a13f2-c269-4f09-e063-6294a90a94d6b0a4ac6b-8f88-8a9a-e053-2995a90ab10e2024-12-12WarningsExact identifier
spl id: 291a13f2-c269-4f09-e063-6294a90a94d6
spl set id: b0a4ac6b-8f88-8a9a-e053-2995a90ab10e

Reported adverse events (FAERS/openFDA)#

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