DECORTE SUN SHELTER MULTI PROTECTION SUNSCREEN SPF 50 BROAD SPECTRUM- avobenzone, homosalate, octinoxate, octisalate lotion

DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad Spectrum by

Drug Labeling and Warnings

DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by KOSÉ America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 7.30% Octisalate 1.00% Avobenzone 3.00% Octinoxate 7.49%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Use as the final step in your morning skin care routine or before makeup. Apply generously and evenly before sun exposure. Reducing the amount of application will lower the level of protection significantly. For removal, use daily cleanser. Avoid contact with clothing and other textiles, as direct contact may stain. If clothing is stained, wash with detergent. Do not use chlorine bleach on stains.

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

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

STOP USE

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 liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply 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 value 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-sleeved shirts, pants, hats, and sunglasses
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun.

Protects skin from UV rays and helps prevent dark spots.
Dermatologically tested.
Free from alcohol, parabens, and mineral oils.

Inactive Ingredients

WATER/AQUA/EAU, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, DIETHYLHEXYL SUCCINATE, CYCLOPENTASILOXANE, PENTYLENE GLYCOL, DEXTRIN PALMITATE, GLYCERIN, ALOE BARBADENSIS LEAF EXTRACT, ASCORBYL TETRAISOPALMITATE, HYDROLYZED COLLAGEN, HYDROXYPROLINE, MALVA SYLVESTRIS (MALLOW) FLOWER/LEAF/STEM EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF WATER, TOCOPHEROL. ACRYLATES/DIMETHICONE COPOLYMER, AGAR, BHT, DIPROPYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, ISOHEXADECANE, OCTYLDODECANOL, PEG-60 GLYCERYL ISOSTEARATE, POLYSORBATE 80, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, XANTHAN GUM, PHENOXYETHANOL, FRAGRANCE (PARFUM).

DESCRIPTION

A sunscreen that protects skin from harmful environmental factors including UVA/UVB rays and dryness. Its lightweight, comfortable texture leaves skin hydrated, supple and radiant.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 60 mL
DECORTÉ 

SUN SHELTER MULTI PROTECTION

Sunscreen

Broad Spectrum

SPF 50+

Lightweight

Hydrating Veil

e 60 mL NET WT. 2.1 OZ.

INGREDIENTS AND APPEARANCE

DECORTE SUN SHELTER MULTI PROTECTION SUNSCREEN SPF 50 BROAD SPECTRUM 
avobenzone, homosalate, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66820-0600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	10 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHYL METHACRYLATE (UNII: 196OC77688)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
HYDROXYPROLINE (UNII: RMB44WO89X)
WATER (UNII: 059QF0KO0R)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
ROSEMARY (UNII: IJ67X351P9)
ROSEMARY OIL (UNII: 8LGU7VM393)
TOCOPHEROL (UNII: R0ZB2556P8)
AGAR (UNII: 89T13OHQ2B)
BHT (UNII: 1P9D0Z171K)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
ISOHEXADECANE (UNII: 918X1OUF1E)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
SORBITAN OLEATE (UNII: 06XEA2VD56)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHYLCELLULOSE (UNII: Z944H5SN0H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66820-0600-1	1 in 1 CARTON	01/05/2025
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/05/2025

Labeler - KOSÉ America, Inc. (080407621)