PHYSICAL TINTED MOISTURIZER SPF44- zinc oxide, titanium dioxide cream

PHYSICAL TINTED MOISTURIZER SPF44 by

Drug Labeling and Warnings

PHYSICAL TINTED MOISTURIZER SPF44 by is a Otc medication manufactured, distributed, or labeled by Drmtlgy, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts

​Active Ingredients

Zinc Oxide 10%

Titanium Dioxide 5.5%

​Purpose

Sunscreen

​Uses

Helps prevent sunburn If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

​Warnings

For external use only.

​When using this product keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.

​Keep out of reach of children.​ If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying at least every 2 hours.

​Precautions

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 value of SPF 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 physician.

​​Inactive Ingredients

Water/Aqua/Eau, Cyclopentasiloxane, Caprylyl Methicone, C12-15 Alkyl Benzoate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Dimethicone, Alumina, Sodium Chloride, Sodium Hyaluronate, Tocopherol, Ascorbyl Palmitate, Polyhydroxystearic Acid, Methicone, Disteardimonium Hectorite, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Propylene Carbonate, 1,2 Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Questions or comments?

1-888-DRMTLGY

SPL UNCLASSIFIED SECTION

MEDICAL GRADE SKIN CARE

PROTECT

Broad Spectrum
UVA/UVB Protection

Water Resistant for up to 80 minutes

Dist. by DRMTLGY, LLC
Chatsworth, CA 91311
www.DRMTLGY.com

Made in USA

Packaging

INGREDIENTS AND APPEARANCE

PHYSICAL TINTED MOISTURIZER SPF44 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83286-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
METHICONE (20 CST) (UNII: 6777U11MKT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83286-010-01	58 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/08/2025

Labeler - Drmtlgy, LLC (094762235)