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
Fully Rice Ceramide Moisture Sunscreen Cream
FDA Label NDC 87343-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Adapt Inc. for the product Fully Rice Ceramide Moisture Sunscreen (NDC 87343-001). 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 - keep out of reach of children, otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, 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%
Homosalate 13.6%
Octisalate 4.5%
Octocrylene 9.0%
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 using and ask a doctor if rash occurs.
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 or higher and other sun protection measures including: - Limit time in the sun, especially from 10 am to 2 pm. - Wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months of age: Ask a doctor
Inactive Ingredient
WATER, BUTYLOCTYL SALICYLATE, PROPANEDIOL, C20-22 ALKYL PHOSPHATE, SILICA, POLYMETHYLSILSESQUIOXANE, C20-22 ALCOHOLS, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, PANTHENOL, METHYL TRIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL STEARATE, VP/EICOSENE COPOLYMER, TROMETHAMINE, POLYACRYLATE CROSSPOLYMER-6, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BUTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, METHYLPROPANEDIOL, POLYETHER-1, CERAMIDE NP, ORYZA SATIVA (RICE) BRAN OIL, TOCOPHEROL, ORYZA SATIVA (RICE) BRAN WATER, BIOSACCHARIDE GUM-1
Other Safety Information
Protect the product in the container from excessive heat and direct sun
* Please review the disclaimer below.
