Active Ingredients
Titanium Dioxide 4.65%
Zinc Oxide 15%
Spf 50 Sheer Mineral Sensitive Sunscreen
FDA Label NDC 79265-8797
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 Spf 50 Sheer Mineral Sensitive Sunscreen (NDC 79265-8797). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Warnings
Contents underpressure. Do not puncture or incinerate can.For external use only.
Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
• Do not use on damaged or broken skin • When using this product • Keep away from face to avoid breathing it • 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.
Do Not Use
• Do not use on damaged or broken skin
When Using This Product
When using this product • Keep away from face to avoid breathing it • Keep out of eyes • Rinse with water to remove •
Stop Use And Ask Doctor
• Stop use and ask doctor if rash occurs
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
• shake well before use • hold container 4 to 6 inches from the skin to apply • apply liberally 15 minutes before sun exposure • do not spray directly into face • do not spray in windy condition • use in well-ventilated area • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.
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
ALOE BARBADENSIS LEAF JUICE*, ALUMINA, BENTONITE, BISABOLOL*, BUTYLOCTYL SALICYLATE, CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER, CAPRYLYL GLYCOL, CELLULOSE GUM, CETEARYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HEPTYL UNDECYLENATE, METHYL DIHYDROABIETATE, MICROCRYSTALLINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, OLEA EUROPAEA (OLIVE) FRUIT OIL, POLYHYDROXYSTEARIC ACID, PROPANEDIOL, PUERARIA LOBATA ROOT EXTRACT*, SILICA, SODIUM GLUCONATE, SODIUM STEAROYL GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, TOCOPHEROL, WATER (AQUA).
*Certified Organic Ingredients
Other Information
Other Information • Protect this product from excessive heat and direct sun. You may report an adverse reaction to the phone number or addresss provided below. May stain some fabrics.
Questions And Comments?
Questions and comments? Call 1-877-537-BABO
Spf 50 Sheer Mineral Sensitive Spray Sunscreen
79265-8797-6. 6 fl oz / 177 mL
* Please review the disclaimer below.
