Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen Spf 50 Lotion
FDA Label NDC 79265-8063

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 Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen Spf 50 (NDC 79265-8063). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Company Information

→ Product Packaging

Active Ingredient

Zinc Oxide (Non-Nano) 20.6%

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

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 A Doctor

if rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control center right away.

Directions

For sunscreen use

apply liberally to exposed areas 15 minutes before sun exposure.
reapply as needed at least every 2 hours or after towel drying, swimming, or sweating
use a water resistant sunscreen if swiming or sweating.

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 sleeves shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Diheptyl Succinate, Calcium Sodium Borosilicate, Octyldodecyl Neopentanoate, Erythritol, Lauryl Laurate, Passiflora Edulis (Maracuja) Seed Oil, Propanediol, Carthamus Tinctorius (Safflower) Oleosomes, Bentonite, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Lupinus Albus (White Lupin) Seed Oil, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Rubus Idaeus (Raspberry) Seed Oil*, Bisabolol*, Tocopherol, Hydrolyzed Wheat Protein/PVP Crosspolymer, Cetearyl Alcohol, Caprylyl Glycol, Ethyl Ferulate, Sucrose Polystearate, Capryloyl Glycerin/Sebacic Acid Copolymer, Sucrose Stearate, Coco-Glucoside, Octyldodecyl Oleate, Iron Oxides, Glycerin, Polyhydroxystearic Acid, Sodium Gluconate, Caprylhydroxamic Acid, Microcrystalline Cellulose, Xanthan Gum.

*Certified Organic Ingredients