TRI-WATER SHEER MINERAL SUNSCREEN CUSHION SPF30- zinc oxide sponge

Tri-water sheer mineral sunscreen cushion SPF30 by

Drug Labeling and Warnings

Tri-water sheer mineral sunscreen cushion SPF30 by is a Otc medication manufactured, distributed, or labeled by Eden Brands Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

ACTIVE INGREDIENT:

Zinc Oxide 18.8%

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.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

DIRECTIONS:

Apply liberally to face and body 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Children under 6 months of age: ask a doctor.

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 your time in the sun, especially from 10 a.m. – 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

OTHER INFORMATION:

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

INACTIVE INGREDIENTS:

Water (Aqua), Glycerin, Isoamyl Laurate, Silica, Caprylic/Capric Triglyceride, Dimethicone, C13-15 Alkane, Squalane, Hydroxyapatite, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Propanediol, Cellulose, Polyglyceryl-4 Oleate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, 1,2-Hexanediol, Polyglyceryl-6 Oleate, Coco-Caprylate/Caprate, Maris Limus Extract, Pongamia Glabra Seed Oil, Lauroyl Lysine, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cucumis Sativus (Cucumber) Fruit Extract, Chimyl Alcohol, Magnolia Officinalis Bark Extract, Pongamia Pinnata Seed Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Tocopherol, Naringin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRI-WATER SHEER MINERAL SUNSCREEN CUSHION SPF30 
zinc oxide sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72113-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	188 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
C13-15 ALKANE (UNII: 114P5I43UJ)
PROPANEDIOL (UNII: 5965N8W85T)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
POLYGLYCERYL-6 OLEATE (UNII: G4AYJ54K59)
COCONUT JUICE (UNII: AMN6S4M09G)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
HYDROXYAPATITE (UNII: 91D9GV0Z28)
CHIMYL ALCOHOL (UNII: UJ10V6YY6H)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
KARUM SEED OIL (UNII: 62160PU6FJ)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
NARINGIN (UNII: N7TD9J649B)
LAUROYL LYSINE (UNII: 113171Q70B)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72113-111-22	1 in 1 CARTON	12/18/2024
1		15 g in 1 CONTAINER; 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	12/18/2024

Labeler - Eden Brands Inc. (081062339)