DAYDREAM CUSHION SUMMER HUE- avobenzone, homosalate, octisalate, titanium dioxide cream

DAYDREAM CUSHION by

Drug Labeling and Warnings

DAYDREAM CUSHION by is a Otc medication manufactured, distributed, or labeled by EM Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 1.5%

Homosalate 8.0%

Octisalate 3.0%

Titanium Dioxide 8.4%

Purpose

Sunscreen

Purpose

Sunscreen

USES

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer, early skin aging by the sun.

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 generously 15 minutes before sun exposure apply to all skin exposed to the sun. Use a water-resistant sunscreen if swimming or sweating.

• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & 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

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENTS

WATER, CYCLOPENTASILOXANE, CAPRYLYL METHICONE, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, CYCLOHEXASILOXANE, NIACINAMIDE, ISOAMYL LAURATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, C12-15 ALKYL BENZOATE, VINYL DIMETHICONE/METHICONE SILSEQUIOXANE CROSSPOLYMER, SODIUM CHLORIDE, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT, ORYZA SATIVA (RICE) EXTRACT, LYCIUM BARBARUM FRUIT EXTRACT, CAMELIA SINENSIS LEAF EXTRACT, HYDROXYACETOPHENONE, TRIMETHYLSILOXYSILICATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIHYDROXYSTEARIN, POLYPROPYLSILSESQUIOXANE, SORBITAN OLIVATE, SORBITAN SESQUIOLATE, SYNTHETIC BEESWAX, TRIETHOXYCAPRYLYLSILANE, DIPROPYLENE GLYCOL, 1,2-HEXANEDIOL, PROPYLENE CARBONATE, DIMETHICONE, DIMETHICONAL, DISTEARDIMONIUM HECTORITE, DISODIUM EDTA, CHLORPHENESIN, IRON OXIDES

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYDREAM CUSHION  SUMMER HUE
avobenzone, homosalate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73586-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PAPAYA (UNII: KU94FIY6JB)
TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)
WHITE RICE (UNII: A195V20H7A)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73586-105-11	12 g in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/06/2020

Labeler - EM Cosmetics LLC (065677626)