ULTRA SHEER MINERAL SUNSCREEN PRO SPF30- zinc oxide lotion

Ultra sheer mineral sunscreen PRO SPF30 by

Drug Labeling and Warnings

Ultra sheer mineral sunscreen PRO 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:

Shake well before use.

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.

INACTIVE INGREDIENTS:

Water (Aqua), Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Squalane, C13-15 Alkane, Polyglyceryl-4 Laurate, Hydroxyapatite, Persea Gratissima (Avocado) Oil, Polyglyceryl-6 Laurate, Isoamyl Laurate, Propanediol, Polyhydroxystearic Acid, 1,2-Hexanediol, Carthamus Tinctorius (Safflower) Oleosomes, Sodium Citrate, Citric Acid, Glyceryl Citrate/Lactate/Linoleate/Oleate, Maris Limus Extract, Sclerotium Gum, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Glycine Soja (Soybean) Seed Extract, Magnolia Officinalis Bark Extract, Chondrus Crispus Extract, Pongamia Pinnata Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Glabra Seed Oil, Trisodium Ethylenediamine Disuccinate, Chimyl Alcohol, Tasmannia Lanceolata Leaf Extract, Hydroxyacetophenone, Sorbitan Isostearate, Phenylpropanol, Caprylyl Glycol, Tocopherol, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Sodium Hyaluronate, Naringin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA SHEER MINERAL SUNSCREEN PRO SPF30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72113-112
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
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
KARUM SEED OIL (UNII: 62160PU6FJ)
SQUALANE (UNII: GW89575KF9)
CHIMYL ALCOHOL (UNII: UJ10V6YY6H)
PERSEA GRATISSIMA (AVOCADO) OIL (UNII: 6VNO72PFC1)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
COCOS NUCIFERA (COCONUT) FRUIT JUICE (UNII: AMN6S4M09G)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-4 LAURATE (UNII: 82V7NG3DYT)
POLYGLYCERYL-6 LAURATE (UNII: Q48X4BL3TV)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
C13-15 ALKANE (UNII: 114P5I43UJ)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TASMANNIA LANCEOLATA LEAF (UNII: H8C2R3TXSF)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
PROPANEDIOL (UNII: 5965N8W85T)
SOYBEAN (UNII: L7HT8F1ZOD)
CUCUMBER (UNII: YY7C30VXJT)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TOCOPHEROL (UNII: R0ZB2556P8)
NARINGIN (UNII: N7TD9J649B)
HYDROXYAPATITE (UNII: 91D9GV0Z28)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE (UNII: A5SAE9KW2M)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
PHENYLPROPANOL (UNII: 0F897O3O4M)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72113-112-14	1 in 1 CARTON	12/18/2024
1		60 g 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	12/18/2024

Labeler - Eden Brands Inc. (081062339)