Label: DAYDREAM BROAD SPECTRUM SUNSCREEN SPF 40- zinc oxide cream
- NDC Code(s): 83286-001-01
- Packager: Drmtlgy, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 3, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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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
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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
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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
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INGREDIENTS AND APPEARANCE
DAYDREAM BROAD SPECTRUM SUNSCREEN SPF 40
zinc oxide creamProduct 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 final part352 02/21/2023 Labeler - Drmtlgy, LLC (094762235)