ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)- homosalate, octinoxate, octisalate, zinc oxide liquid

ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50) by

Drug Labeling and Warnings

ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50) by is a Otc medication manufactured, distributed, or labeled by ZITSTICKA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts.

Active Ingredients

Homosalate 7.50% Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 3.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection
• 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 or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use

Directions:

Apply liberally 15 minutes before sun exposure Children under 6 months of age: ask a doctor. Reapply at least every 2 hours Reapply as needed  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 the risk, regularly use a sunscreen with broad spectrum SPF 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.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Teat) Extract, Caprylic/Capric Triglyceride, Carbomer, Citric Acid, Citrullus Lantus (Watermelon) Extract, Ceramide NG, Cetearyl Alcohol, Cetearyl Glucoside, Cocamidopropyl Betaine, Colloidal Oatmeal, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ferulic Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hyaluronic Acid, Hydrogenated Methyl Abietate, Hydropropyl Cyclodextrin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Phenyl Trimethicone, Polysorbate-20, Terminalia Ferdinandiana (Kakadu Plum) Oil, Thymus Vulgaris (Thyme) Extract.

Other Information:

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

Questions?

+1 (424) 274 4500

Package Labeling:81746-183-00

Package Labeling:81746-183-01

INGREDIENTS AND APPEARANCE

ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50) 
homosalate, octinoxate, octisalate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81746-183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	75 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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
CERAMIDE NG (UNII: C04977SRJ5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
OATMEAL (UNII: 8PI54V663Y)
CARROT (UNII: L56Z1JK48B)
DODECANE (UNII: 11A386X1QH)
FERULIC ACID (UNII: AVM951ZWST)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
HYALURONIC ACID (UNII: S270N0TRQY)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
NIACINAMIDE (UNII: 25X51I8RD4)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
THYME (UNII: CW657OBU4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81746-183-00	1 in 1 BOX	04/10/2021
1		50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 81746-183-01	1 in 1 BOX	09/01/2021
2		30 mL in 1 BOTTLE, DROPPER; 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	04/10/2021

Labeler - ZITSTICKA, Inc (117778611)