Statement Of Identity
Haruharu wonder - Centella Calm Cloud SPF
Haruharu Wonder - Centella Calm Cloud Spf Cream
FDA Label NDC 87557-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dfs Company for the product Haruharu Wonder - Centella Calm Cloud Spf (NDC 87557-002). 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 statement of identity, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Avobenzone 2.7% …………… Sunscreen
Homosalate 13.6% …………… Sunscreen
Octisalate 4.5% …………… Sunscreen
Octocrylene 9.0% …………… Sunscreen
Otc - Purpose
Sunscreen
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.
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.
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.
Dosage & Administration
Directions
Apply liberally and evenly 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: limit time in the sun, especially from 10 a.m.–2 p.m.; wear long-sleeved shirts, pants, hats, and sunglasses.
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
Water, Butyloctyl Salicylate, Propanediol, Polymethylsilsesquioxane, C20‑22 Alkyl Phosphate, C20‑22 Alcohols, 1,2‑Hexanediol, Pentylene Glycol, Panthenol, Methyl Trimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Stearate, VP/Eicosene Copolymer, Tromethamine, Polyacrylate Crosspolymer‑6, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethylhexylglycerin, Butylene Glycol, Methylpropanediol, Polyether‑1, Ceramide NP, Sodium Hyaluronate, Tocopherol, Biosaccharide Gum‑1, Centella Asiatica Extract.
Otc - Questions
Questions or comments?
1-305-921-4121
You may report serious side effects to this number.
Contact email: [email protected]
Package Label.Principal Display Panel
Artwork (Artwork)
Centella Calm Cloud SPF
Soothing · Invisible Finish
Broad Spectrum SPF 60+
Avobenzone, Homosalate, Octisalate, Octocrylene
Sunscreen Cream
50 mL / 1.69 fl. oz
* Please review the disclaimer below.
