BENEFIT DREAM SCREEN BROAD SPECTRUM SPF 45 SUNSCREEN FOR FACE- avobenzone, octinoxate, octisalate cream
Benefit Cosmetics, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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benefit DREAM SCREEN BROAD SPECTRUM SPF 45 SUNSCREEN FOR FACE

Active Ingredients

Avobenzone 3.00%
Octinoxate 7.50%
Octisalate 5.00%

Purpose

Sunscreen

Use

Helps to 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.

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 swallowed, get medical help or contact Poison Control center right away.

Directions

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a Water resistant sunscreen if swimming or sweating.
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. 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 sun, especially from 10 a.m. till 2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

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

Inactive Ingredients

C12-15 Alkyl Benzoate, Aqua (Water), Butylene Glycol, Polymethylsilsesquioxane, Polymethyl Methacrylate, Isononyl Isononanoate, Methyl Methacrylate Crosspolymer, Dicaprylyl Carbonate, Glycerin, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Pentylene Glycol, Polyglyceryl-6 Polyricinoleate, Phenoxyethanol, Sodium Chloride, Polyglyceryl-2 Isostearate, Tetrasodium Edta, Tocopherol, Stearyl Glycyrrhetinate.

Package Labeling:

Label

BENEFIT DREAM SCREEN BROAD SPECTRUM SPF 45 SUNSCREEN FOR FACE
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66472-041
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
EDETATE SODIUM (UNII: MP1J8420LU)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66472-041-01	45 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019	08/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/12/2013	08/31/2020

Labeler - Benefit Cosmetics, LLC (070826813)

Revised: 12/2020

Document Id: b7b4ffa8-0375-a019-e053-2995a90a5725

Set id: 3b9bfa60-e083-4bd0-afd5-7acb5112d4b6

Version: 5

Effective Time: 20201230

Benefit Cosmetics, LLC