Active Ingredients
Homosalate 12%, Octisalate 4.8%, Octocrylene 4.5%, Avobenzone 2.8%
Hydroscreen Cream
FDA Label NDC 87110-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Methodiq Inc. for the product Hydroscreen (NDC 87110-005). 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 ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Purpose
Homosalate 12%, Octisalate 4.8%, Octocrylene 4.5%, Avobenzone 2.8%..................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
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product Keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply generously 15 minutes before sun exposure.
- Children under 6 months of age: ask a doctor.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
- 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:
- Limited time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirt, pants, hats, and sunglasses.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Water, Dipropylene Glycol, Cyclopentasiloxane, NIacinamide, Butyloctyl Salicylate, Cyclohexasiloxane, Pentylene Glycol, Polymethylsilsesquioxane, Silica, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Methylpropanediol, Butylene Glycol, Betaine, Panthenol, 1,2-Hexanediol, Xanthan Gum, Acacia Senegal Flower/Stem Extract, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Caprylyl Glycol, Adenosine, Glycerin, Pyrus Communis (Pear) Fruit Extract, Rosa Damascena Flower Water, Mangifera Indica (Mang) Fruit Extract, Allantoin, Iris Florentina Root Extract, Ethyl Hexanediol, Cucumis Melo (Melon) Fruit Extract, Hydrolyzed Extensin, Hydrogenated Extensin, Hydrogenated Lecithin, Steareth-30, Hedera Helix (Ivy) Leaf/Stem Extract, Cetearyl Alcohol, Melia Azadirachta Leaf Extract, Stearic Acid, Narcissus Tazetta Extract, Tuber Magnatum Extract, Hydrolyzed Collagen, Ceramide NP, Cholesterol, Phytosphingosine, Ceramide NG, Ceramide NS, Ceramide AS, Ceramide AP, Collagen Extract, Ceramide EOP, Sodium Polyphosphate
Package Label.Principal Display Panel
10ml
0.3 Fl. Oz. e
HydroScreen
Broad Spectrum SPF 30 Sunscreen
Niacinamide, Hydrolyzed Collagen, Ceramides, Allantoin
Apply generously and evenly 15 minutes before sun exposure.
* Please review the disclaimer below.
