Otc - Active Ingredient
Diethylhexyl Butamido Triazone 1.2%
Bisoctrizole 2%
Octyl Triazone (ethylhexyl triazone) 2.4%
Diethylamino Hydroxybenzoyl Hexyl Benzoate 3%
Calming Days Vegan Sunscreen Gel
FDA Label NDC 85940-307
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mercyco Co., Ltd. for the product Calming Days Vegan Sunscreen (NDC 85940-307). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
• 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
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove
Otc - Stop Use
Stop use and ask a 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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
Do not use on damaged or broken skin
Dosage & Administration
• apply evenly 15 minutes before sun exposure
• reapply:
• at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increase 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 sun 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 Ingredient
Water, Dibutyl Adipate, Propanediol, Polymethylsilsesquioxane,
Diisopropyl Sebacate, Coco-Caprylate/Caprate, 1,2-Hexanediol,
Butylene Glycol, Glycerin, Caprylyl Methicone, Solanum
Tuberosum (Potato) Pulp Extract, Centella Asiatica Extract,
Olea Europaea (Olive) Fruit Oil, Abies Sibirica Oil, Rosmarinus
Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Pelargonium
Graveolens Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil,
Pogostemon Cablin Oil, Chamomilla Recutita (Matricaria) Flower
Oil, Juniperus Mexicana Oil, Anthemis Nobilis Flower Oil,
Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Pentylene
Glycol, Behenyl Alcohol, Poly C10-30 Alkyl Acrylate, Polyglyceryl-3
Methylglucose Distearate, Xylitylglucoside, Decyl Glucoside,
Anhydroxylitol, Tromethamine, Carbomer, Acrylates/C10-30 Alkyl
Acrylate Crosspolymer, Xylitol, Polyquaternium-51, Sodium Stearoyl
Glutamate, Polyacrylate Crosspolymer-6, Ethylhexylglycerin,
Glucose, Xanthan Gum, T-Butyl Alcohol, Tocopherol, Ascorbic Acid
Polypeptide
85940
sunscreen
85940 (85940 1)
* Please review the disclaimer below.
