79265-8077 Babo SPF 30 Clear Zinc, Fragrance Free Sunscreen Lotion

Manufacturer
Babo Botanicals, Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:30

Label at a glance#

ProductBabo SPF 30 Clear Zinc Fragrance Free
Active ingredientZINC OXIDE
Label structure14 sections

Indications and uses

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.

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.

Label contents#

Full prescribing information#

79265-8077 SPF 30 Clear Zinc, Fragrance Free Sunscreen Lotion

SPL UNCLASSIFIED SECTION

79265-8077-3 3 fl. oz.

This is an OTC Sunscreen product manufactured pursuant to the sunscreen final monograph, Part352.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16.0%

Purpose

OTC - PURPOSE SECTION

Purpose: Sunscreen

Stop use and ask doctor

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

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

Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

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.

Sun Protection Measures

OTHER SAFETY INFORMATION

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 of 15 or higher and other protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor

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

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Questions and comments?

SPL UNCLASSIFIED SECTION

Questions and comments?Call 1-877-537-BABO

Information Panel

SPL UNCLASSIFIED SECTION

Dist: by Babo Botanicals, Inc.

14 Harwood Court, Scarsdale, NY 10583

1.877.537.BABO www.babobotanicals.com

MADE IN THE USA with US & imported materials.

Uses

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.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Babo Botanicals

Clear Zinc Sunscreen

Broad Spectrum SPF 30

Hypoallergenic

Fragrance Free

For Babies, Kids & Grown Ups Too!

3 fl oz / 89 ml

Principal Display PanelPrincipal Display Panel

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
79265-8077-3Babo SPF 30 Clear Zinc Fragrance Free89 mL in 1 TUBELOTION895

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8077BABO SPF 30 CLEAR ZINC FRAGRANCE FREE (MINERAL SUNSCREEN) LOTION [BABO BOTANICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20241215_b3e40cb0-dbfd-955c-e053-2995a90af848.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
79265-807779265-8077-3

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
Babo SPF 30 Clear Zinc Fragrance FreeMINERAL SUNSCREENBabo Botanicals, Inc.b3e40cb0-dbfd-955c-e053-2995a90af8482024-12-12WarningsExact identifier
ndc (package): 79265-8077-3
ndc (product): 79265-8077
ndc11 (package): 79265807703
spl id: 291a2b1d-a360-195b-e063-6394a90ab994
spl set id: b3e40cb0-dbfd-955c-e053-2995a90af848

Reported adverse events (FAERS/openFDA)#

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