DREAMBEAM SUNSCREEN- sunscreen zinc oxide lotion

DreamBeam Sunscreen by

Drug Labeling and Warnings

DreamBeam Sunscreen by is a Otc medication manufactured, distributed, or labeled by Kosas Cosmetics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dosage

Directions:
Apply liberally 15 minutes before sun exposure.
Children under 6 months of age: ask a doctor.
Sun Protection Measures:

Spending time in the sun increases your risk of skin cancer and early skin aging.
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 10am - 2pm, wear long-sleeved shirts, pants, hats, and sunglasses.

Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Warnings

Warnings:

For external use only.

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

Stop use and ask a doctor is rash occurs.

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

Do not use on damaged or broken skin.

INACTIVE INGREDIENT

Use

Use:

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.

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.

Purpose

Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DREAMBEAM SUNSCREEN 
sunscreen zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82554-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CERAMIDE NG (UNII: C04977SRJ5)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICA (UNII: V8A1AW0880)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
LACTIC ACID (UNII: 33X04XA5AT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FYTIC ACID (UNII: 7IGF0S7R8I)
XANTHAN GUM (UNII: TTV12P4NEE)
CYAMOPSIS TETRAGONOLOBA WHOLE (UNII: K97Q182I2L)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
C13-15 ALKANE (UNII: 114P5I43UJ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GALACTOARABINAN (UNII: SL4SX1O487)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ALPHA-2-HS-GLYCOPROTEIN (UNII: B3AM8SX9GW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82554-102-40	1 in 1 BOX	04/14/2023
1		40 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	04/14/2023

Labeler - Kosas Cosmetics, LLC (080697604)