Otc - Active Ingredient
Octinoxate 7.0%
Zinc Oxide 2.94%
Titanium Dioxide 2.4%
Smts Dual Ha Sun Block
FDA Label NDC 84609-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sonovio Llc for the product Smts Dual Ha Sun Block (NDC 84609-001). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Uses
A light, multi-purpose antioxidant day cream formulated to moisturize and protect from photodamage.
Warnings
①For external use only.
② When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
③Stop use and ask a doctor if irrrtion or rash occurs. These may be signs of a serious condition.
④Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away,
⑤If swallowed, get medical help or contact a Poison Control Center rightaway.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away,
Directions
After cleansing, apply generously to entire face and neck area 15-30 mins prior to sun exposure. Reapply as needed.
Other Information
Store between 15-30C (59-86F)
Inactive Ingredients
Water, Cyclopentasiloxane, Butylene Glycol, Cetyl Ethylhexanoate, Dimethicone Copolyol, Cyclohexasiloxane,
Cyclomethicone, Quaternium-18 Bentonite, lsopropyl Myristate , PEG-10 Glyceryl Triisostearate,
Butyrospermum Parkii (Shea) Butter, Hexyl Laurate, Magnesium Sulfate, Alumina, Chlorphenesin, Fragrance,
Tocopheryl Acetate, Dimethicone, Allantoin, Griffonia Simplicifolia Seed Extract, Phenoxyethanol, Sodium
Hyaluronate, Scutellaria Baicalensis Root Extract, Ethylhexylglycerin, Alpha-lsomethyl lonone, Benzyl Salicylate,
Citronellol, Limonene, Geraniol, Linalool
Package Label.Principal Display Panel
Undefined (Label)
* Please review the disclaimer below.
