Drug labels

Ultra sheer mineral sunscreen PRO SPF30

ZINC OXIDE · Eden Brands Inc. · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
2ce06566-2eb0-9a00-e063-6394a90a9ba9
ID
2ce06566-2eb1-9a00-e063-6394a90a9ba9
Effective time
20250214
Version
1
SPL product data elements

Ultra sheer mineral sunscreen PRO SPF30 Zinc Oxide POLYHYDROXYSTEARIC ACID (2300 MW) CITRIC ACID MONOHYDRATE DUNALIELLA SALINA HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) KARUM SEED OIL SQUALANE CHIMYL ALCOHOL PERSEA GRATISSIMA (AVOCADO) OIL SCLEROTIUM GUM COCOS NUCIFERA (COCONUT) FRUIT JUICE XANTHAN GUM POLYGLYCERYL-4 LAURATE POLYGLYCERYL-6 LAURATE 1,2-HEXANEDIOL C13-15 ALKANE GLYCERIN DIMETHICONE WATER CAPRYLIC/CAPRIC TRIGLYCERIDE TRISODIUM ETHYLENEDIAMINE DISUCCINATE TASMANNIA LANCEOLATA LEAF ISOAMYL LAURATE PROPANEDIOL SOYBEAN CUCUMBER HYDROXYACETOPHENONE SORBITAN ISOSTEARATE TOCOPHEROL NARINGIN HYDROXYAPATITE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES SODIUM CITRATE GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE ALOE BARBADENSIS LEAF JUICE PONGAMIA PINNATA SEED PHENYLPROPANOL ZINC OXIDE ZINC OXIDE MAGNOLIA OFFICINALIS BARK CHONDRUS CRISPUS CARRAGEENAN SODIUM HYALURONATE CAPRYLYL GLYCOL HAEMATOCOCCUS PLUVIALIS

Statement of identity
SPF 30 PRO Primary
Active ingredient
ACTIVE INGREDIENT: Zinc Oxide 18.8%
Purpose
PURPOSE: Sunscreen
Indications and usage

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

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.

Do not use
• Do not use on damaged or broken skin.
Stop use
• Stop use and ask a doctor if rash occurs
When using
When using this product keep out of eyes. Rinse with water to remove.
Keep out of reach of children
• Keep out of reach of children.
Dosage and administration

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 ingredient

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

Package label principal display panel
SPF 30 PRO Secondary
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Ultra sheer mineral sunscreen PRO SPF30
Generic name
ZINC OXIDE
Manufacturer name
Eden Brands Inc.
Product NDC
72113-112
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
ZINC OXIDE
SPL ID
2ce06566-2eb1-9a00-e063-6394a90a9ba9
SPL set ID
2ce06566-2eb0-9a00-e063-6394a90a9ba9
Package NDC
72113-112-14
Is original packager
true
Upc
0850068719075
UNII
SOI2LOH54Z
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.