DAYDREAM BROAD SPECTRUM SUNSCREEN SPF 40- zinc oxide cream

DAYDREAM Broad Spectrum Sunscreen SPF 40 by

Drug Labeling and Warnings

DAYDREAM Broad Spectrum Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Drmtlgy, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 17% w/v

Purpose

Sunscreen

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.

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 a Poison Control Center right away.

Directions

apply generously to face and neck avoiding eye area 15 minutes before sun exposure.
reapply:
  after 80 minutes of swimming or sweating
     immediately after towel drying
  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
children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, Isododecane, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Coco-Caprylate/Caprate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyhydroxystearic Acid, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Fructooligosaccharide, Glycoproteins, Bioflavonoids, Cyamopsis Tetragonoloba (Guar) Gum, Glycerin, Butyrospermum Parkii (Shea) Butter, 1,2-Hexanediol, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysorbate 20, Pentylene Glycol, Decyl Glucoside, Xanthan Gum

SPL UNCLASSIFIED SECTION

MEDICAL GRADE SKIN CARE

UVA/UVB Protection

100% Mineral Filters

Water & Sweat Resistant (80 Minutes)

Oil-Free

Vegan

Paraben Free

Sulfate Free

Gluten Free

Fragrance Free

Never Tested On Animals

Made in USA with globally sourced components.
Distributed by: DRMTLGY, LLC
Canoga Park, CA 91304
www.DRMTLGY.com

Packaging

INGREDIENTS AND APPEARANCE

DAYDREAM BROAD SPECTRUM SUNSCREEN SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83286-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENYLSILANETRIOL (UNII: DNR46JQ8BT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SACCHARUM OFFICINARUM STEM FRUCTOOLIGOSACCHARIDES (UNII: 8LLD82AE3S)
PLATELET GLYCOPROTEIN VI (UNII: L2RO3AL4JN)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
GUAR GUM (UNII: E89I1637KE)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83286-001-01	1 in 1 CARTON	02/21/2023
1		50 mL in 1 JAR; 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	02/21/2023

Labeler - Drmtlgy, LLC (094762235)