Otc - When Using
■ Keep out of eyes. Rinse with water to remove.
Bubble And Co Daily Defense Sunscreen Cream
FDA Label NDC 88119-111
13 label sections · Submitted to the FDA by Dear U International Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dear U International Inc. for the product Bubble And Co Daily Defense Sunscreen (NDC 88119-111). 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 - when using, otc - active ingredient, otc - do not use, otc - keep out of reach of children, dosage & administration, otc - purpose, storage and handling, inactive ingredient, 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 13.5% Octisalate 4.5% Octocrylene 9.0%
Otc - 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.
Dosage & Administration
■ Apply liberally 15 minutes before sun exposure.
■ Reapply at least every 2 hours.
■ Use a water-resistant sunscreen if swimming or sweating.
■ Children under 6 months of age: Ask a doctor.
■ 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 higher and other sun protection measures including:
■ limit time in the sun, especially from 10 a.m. to 2 p.m.
■ Wear long-sleeved shirts, pants, hats, and sunglasses.
Otc - Purpose
Purpose-Sunscreen
Storage And Handling
■ Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
WATER, BUTYLOCTYL SALICYLATE, DIETHYLHEXYL 2, 6-NAPHTHALATE, DIPROPYLENE GLYCOL, PANTHENOL, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS,1,2-HEXANEDIOL, SILICA, CAPRYLYL METHICONE, PENTYLENE GLYCOL,CETYL ALCOHOL, GLYCERYL STEARATE, VP/EICOSENE COPOLYMER, POLYMETHYLSILSESQUIOXANE, TROMETHAMINE, POLYACRYLATE CROSSPOLYMER-6, AMMONIUM ACRYLOYLDIMETHYLTAURATE /VP COPOLYMER, ETHYLHEXYLGLYCERIN, HYDROLYZED SODIUM HYALURONATE, TOCOPHEROL, BUTYLENE GLYCOL, CAMELLIA SINENSIS LEAF EXTRACT, CENTELLA ASIATICA EXTRACT
Otc - Questions
Questions or Comments
[email protected]
+1 929 458 1844
Otc - Stop Use
■ rash occurs.
Warnings
For external use only.
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.
Package Label.Principal Display Panel
package principal display
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