Drug labels

Dr.Ceuracle HYDRA BARRIER SUNSCREEN

ZINC OXIDE · Leegeehaam Cosmetics · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
22c05215-4983-b32e-e063-6394a90a9f67
ID
32a42694-620d-fddb-e063-6294a90ad623
Effective time
20250413
Version
2
SPL product data elements

Dr.Ceuracle HYDRA BARRIER SUNSCREEN Zinc Oxide LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) ECHIUM PLANTAGINEUM SEED OIL CARDIOSPERMUM HALICACABUM FLOWERING TOP HYALURONATE SODIUM WATER BUTYLOCTYL SALICYLATE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) CAPRYLYL GLYCOL OCTYLDODECANOL ETHYLHEXYLGLYCERIN TOCOPHEROL SUNFLOWER OIL UNSAPONIFIABLES PANTHENOL METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER TRIETHOXYCAPRYLYLSILANE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE PROPANEDIOL ZINC OXIDE ZINC OXIDE PROPYLHEPTYL CAPRYLATE CAPRYLYL TRISILOXANE POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) MAGNESIUM SULFATE, UNSPECIFIED 1,2-HEXANEDIOL ISODODECANE CITRIC ACID MONOHYDRATE GLYCERYL CAPRYLATE DISTEARDIMONIUM HECTORITE

Active ingredient
Active Ingredient...Purpose Zinc Oxide 17% ....... Sunscreen
Purpose

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

Warnings

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

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

Instructions for use

Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. 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 from 10 a.m.-2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredient

Inactive ingredients Water, Propylheptyl Caprylate, Butyloctyl Salicylate, Propanediol, Caprylyl Methicone, Isododecane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Magnesium Sulfate, Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glyceryl Caprylate, Caprylyl Glycol, Octyldodecanol, Ethylhexylglycerin, Echium Plantagineum Seed Oil, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hyaluronate, Panthenol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid

Storage and handling
Other information Protect the product in this container from excessive heat and direct sun.
Dosage and administration
Dosage and Administration Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
Keep out of reach of children
Keep out of reach of children Keep out of reach of children
Indications and usage

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.

Package label principal display panel
Hydra Barrier Sunscreen
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Dr.Ceuracle HYDRA BARRIER SUNSCREEN
Generic name
ZINC OXIDE
Manufacturer name
Leegeehaam Cosmetics
Product NDC
84773-001
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
ZINC OXIDE
SPL ID
32a42694-620d-fddb-e063-6294a90ad623
SPL set ID
22c05215-4983-b32e-e063-6394a90a9f67
Package NDC
84773-001-01, 84773-001-02, 84773-001-03
Is original packager
true
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.