CALMING DAYS VEGAN SUNSCREEN (diethylamino hydroxybenzoyl hexyl benzoate, octyl triazone- ethylhexyl triazone, bisoctrizole, diethylhexyl butamido triazone gel

Calming Days Vegan Sunscreen by

Drug Labeling and Warnings

Calming Days Vegan Sunscreen by is a Otc medication manufactured, distributed, or labeled by Merci Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Diethylamino Hydroxybenzoyl Hexyl Benzoate 3%

Octyl Triazone (ethylhexyl triazone) 2.4%

Bisoctrizole 2%

Diethylhexyl Butamido Triazone 1.2%

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

Warnings

When using this product keep out of eyes. Rinse with water to remove

Warnings

Stop use and ask a doctor if rash occurs

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Do not use on damaged or broken skin

Directions

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 ingredients

Water, Dibutyl Adipate, Propanediol, Polymethylsilsesquioxane,

Diisopropyl Sebacate, Niacinamide, 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, Adenosine, Xanthan Gum, T-Butyl Alcohol, Tocopherol, Ascorbic Acid Polypeptide

Display Panel

INGREDIENTS AND APPEARANCE

CALMING DAYS VEGAN SUNSCREEN 
diethylamino hydroxybenzoyl hexyl benzoate, octyl triazone (ethylhexyl triazone), bisoctrizole, diethylhexyl butamido triazone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83020-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	3 g  in 100 mL
BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS)	BISOCTRIZOLE	2 g  in 100 mL
ISCOTRIZINOL (UNII: 2UTZ0QC864) (ISCOTRIZINOL - UNII:2UTZ0QC864)	ISCOTRIZINOL	1.2 g  in 100 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	2.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIBUTYL ADIPATE (UNII: F4K100DXP3)
GLYCERIN (UNII: PDC6A3C0OX)
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
POTATO PULP (UNII: 844I2DX0IS)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CLOVE LEAF OIL (UNII: VCA5491KVF)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DOCOSANOL (UNII: 9G1OE216XY)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
OLIVE OIL (UNII: 6UYK2W1W1E)
ROSEMARY OIL (UNII: 8LGU7VM393)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
TROMETHAMINE (UNII: 023C2WHX2V)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ADENOSINE (UNII: K72T3FS567)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
NIACINAMIDE (UNII: 25X51I8RD4)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
XYLITOL (UNII: VCQ006KQ1E)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83020-401-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/01/2024

Labeler - Merci Co. (695131837)

Registrant - Merci Co. (695131837)

Establishment
Name	Address	ID/FEI	Business Operations
Merci Co.		695131837	manufacture(83020-401)