79265-8077 Spf 30 Clear Zinc, Fragrance Free Sunscreen Lotion
79265-8077-3 3 fl. oz.
This is an OTC Sunscreen product manufactured pursuant to the sunscreen final monograph, Part352.
Babo Spf 30 Clear Zinc Fragrance Free Lotion
FDA Label NDC 79265-8077
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Babo Botanicals, Inc. for the product Babo Spf 30 Clear Zinc Fragrance Free (NDC 79265-8077). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 79265-8077 spf 30 clear zinc, fragrance free sunscreen lotion, active ingredients, purpose, stop use and ask doctor, warnings, keep out of reach of children, directions, sun protection measures, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Zinc Oxide 16.0%
Purpose
Purpose: Sunscreen
Stop Use And Ask Doctor
Stop use and ask doctor if rash occurs.
Warnings
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
Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.
Directions
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
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
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
Protect this product from excessive heat and direct sun
Questions And Comments?
Questions and comments?Call 1-877-537-BABO
Information Panel
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
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
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 Panel (8077)
* Please review the disclaimer below.
