Active Ingredient...Purpose
Zinc Oxide 17% ....... Sunscreen
Dr.ceuracle Hydra Barrier Sunscreen Lotion
FDA Label NDC 84773-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leegeehaam Cosmetics for the product Dr.ceuracle Hydra Barrier Sunscreen (NDC 84773-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient...purpose, uses, warnings, directions, inactive ingredients, other information, dosage and administration, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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.
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Sun Protection Measures.
- Limit time in the sun, especially from 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
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:
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
Other Information
- Protect the product in this container from excessive heat and direct sun.
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
Indications & 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.
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