Spf 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, Ff
This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide
Babo Baby Skin Mineral Sunscreen Ff
FDA Label NDC 79265-8579
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 Baby Skin Mineral Sunscreen Ff (NDC 79265-8579). 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 spf 30 baby skin mineral non-aerosol sunscreen pump spray, ff, active ingredient, uses, purpose, warnings, do not use, when using this product, stop use and ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 14.5%; Purpose: Sunscreen
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
Purpose
Sunscreen
Warnings
For external use only.
Do Not Use
- on damaged or broken skin.
When Using This Product
Keep out of eye. Rinse with water to remove.
Stop Use And Ask Doctor
if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If 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• 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. and wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months; ask a doctor.
Inactive Ingredients
BENTONITE
BISABOLOL*
BUTYLOCTYL SALICYLATE
CALENDULA OFFICINALIS FLOWER EXTRACT*
CAPRYLHYDROXAMIC ACID
CAPRYLIC/CAPRIC TRIGLYCERIDE
CAPRYLYL GLYCOL
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL
CELLULOSE GUM
CETEARYL ALCOHOL
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*
COCO GLUCOSIDE
GLYCERIN*
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*
JOJOBA ESTERS
METHYL DIHYDROABIETATE
MICROCRYSTALLINE CELLULOSE
NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*
POLYHYDROXYSTEARIC ACID
PROPANEDIOL
PUERARIA LOBATA (KUDZU) ROOT EXTRACT*
SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*
TETRADECANE
TOCOPHEROL
WATER (AQUA)
Other Information
Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.
Questions And Comments
Call toll free 1-877-537-BABO Monday-Friday 9:00 am - 5:00 EST
Package Label.Principal Display Panel
79265-8579-6 6 fl. oz. / 177 mL
* Please review the disclaimer below.
