DailyMed - DREAMBEAM SUNSCREEN SUNLIT- sunscreen zinc oxide lotion

NDC Code(s): 82554-103-40
Packager: Kosas Cosmetics, LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated February 13, 2025

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Directions
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 ...

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, and reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours
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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 if rash occurs. Keep out of reach of children. If ...

Warnings:
For external use only
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 swallowed, get medical
help or contact a Poison Control Center right away.

Do not use on damaged or broken skin.
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INACTIVE INGREDIENT

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Use
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.

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.
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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.
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Purpose
Sunscreen

Sunscreen
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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

Product Information

DREAMBEAM SUNSCREEN SUNLIT sunscreen zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82554-103
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82554-103-40	1 in 1 BOX	04/14/2023
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/14/2023

Labeler - Kosas Cosmetics, LLC (080697604)

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DREAMBEAM SUNSCREEN SUNLIT- sunscreen zinc oxide lotion

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DREAMBEAM SUNSCREEN SUNLIT- sunscreen zinc oxide lotion

DREAMBEAM SUNSCREEN SUNLIT- sunscreen zinc oxide lotion

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DREAMBEAM SUNSCREEN SUNLIT- sunscreen zinc oxide lotion

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.