YOUR DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30- octisalate, oxybenzone, avobenzone, octocrylene cream

YOUR Day Cream Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

YOUR Day Cream Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Skin Ai, LLC, Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 3%

Octisalate 4.75%

Octocrylene 2.8%

Oxybenzone 4.25%

Purpose

Sunscreen

Uses

Help prevent sunburn.

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. *For children under 6 months of age: Ask a doctor.

Inactive ingredients

Water (Aqua), Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Isopropyl Palmitate, Potassium Cetyl Phosphate, Glycerin, Acrylates / C12-22 Alkyl Methacrylate Copolymer, Cetearyl Alcohol, Magnesium Aluminum Silicate, Cyclopentasiloxane, Tocopheryl Acetate (Vitamin E), Dimethicone, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Polyacrylate Crosspolymer-6, Xanthan Gum, Tetrasodium Ethylenediaminetetraacetate, Allantoin, Camellia Sinensis (Green Tea) Leaf Extract, Sodium Ascorbyl Phosphate (Vitamin C).

Other information

Protect the product in this container from excessive heat and direct sun.

Principal Display Panel

clean + customized

2

DAY

CREAM

sunscreen SPF30

broadspectrum

Y'OUR

30 g (Net WT 1 Oz)

INGREDIENTS AND APPEARANCE

YOUR DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30 
octisalate, oxybenzone, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84229-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.25 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.8 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
EDETATE SODIUM (UNII: MP1J8420LU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84229-0017-1	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/18/2024

Labeler - Skin Ai, LLC (003716972)

Registrant - Columbia Cosmetics Manufacturing, Inc. (068267863)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(84229-0017)