MATTE TINTED SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion

Matte Tinted Sunscreen SPF 50 by

Drug Labeling and Warnings

Matte Tinted Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by CLINICAL SKIN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 5.8%

Zinc Oxide 14.4%

Purpose

Sunscreen

Use

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 liberally 15 minutes before sun exposure

reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating

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 from10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Other Information

store at Room Temperature (15 C-25 C (59 F-77 F)

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

Inactive ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Alumina, Aqua (Water), Ascorbic Acid, Bioflavonoids, Brassica Oleracea Italica (Broccoli) Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NG, Ceramide NP, Cetearyl Alcohol, Cetearyl Glucoside, Cholesterol, Dicaprylyl Carbonate, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Iron Oxides (CI 77491, CI77492, CI 77499), Lauryl Glucoside, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Niacinamide, Phenoxyethanol, Phytosphingosine, Polyglyceryl-2 Dipolyhydroxystearate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium C14-16 Olefin Sulfonate, Sodium Lauroyl Lactylate, Sodium Stearoyl Glutamate, Stearic Acid, Superoxide Dismutase, Tocopherol, Trie- thoxycaprylylsilane, Xanthan Gum

PRINCIPAL DISPLAY PANEL

CLINICAL+ SKIN

MATE TINTED SUNSCREEN

UV BROAD SPECTRUM

SPF50

100% MINERAL

SHIELDS AGAINST

UVA/UVB RAYS

OIL-BALANCED

FINISH

1.7 FL OZ/50 ML

INGREDIENTS AND APPEARANCE

MATTE TINTED SUNSCREEN SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84248-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CERAMIDE NG (UNII: C04977SRJ5)
PROPANEDIOL (UNII: 5965N8W85T)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
MUSKMELON (UNII: ZV095H5633)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BROCCOLI SEED OIL (UNII: SY01LVD4G4)
CERAMIDE AP (UNII: F1X8L2B00J)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CERAMIDE NP (UNII: 4370DF050B)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
NIACINAMIDE (UNII: 25X51I8RD4)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE (UNII: 92RU3N3Y1O)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84248-026-01	1 in 1 CARTON	06/17/2024
1		50 mL in 1 BOTTLE; 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	06/17/2024

Labeler - CLINICAL SKIN LLC (106954468)

Registrant - CLINICAL SKIN LLC (106954468)