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
Obge Pore-zero Oil Control Sun Stick
FDA Label NDC 87343-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Adapt Inc. for the product Obge Pore-zero Oil Control Sun Stick (NDC 87343-002). 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 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 2.8%
Homosalate 9.5%
Octisalate 4.5%
Octocrylene 5.0%
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
Methyl Methacrylate Crosspolymer, Ethylhexyl Isononanoate, Synthetic Wax, Dimethicone/Vinyl Dimethicone Crosspolymer, Diethylhexyl Carbonate, Butyloctyl Salicylate, Diphenylsiloxy Phenyl Trimethicone, Isopropyl Palmitate, Dimethicone, Phenethyl Benzoate, Diisostearyl Malate, Dimethiconol, Trisiloxane, Phenyl Propyl Trimethicone, Synthetic Fluorphlogopite, Ethylhexyl Methoxycrylene, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polyethylene, Ethylene/Propylene Copolymer, Camellia Japonica Seed Oil, Silica Dimethyl Silylate, Candelilla Wax Esters, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Copernicia Cerifera (Carnauba) Wax, Water, Dipropylene Glycol, Madecassoside, Zinc PCA, Butylene Glycol, Propanediol, Asiaticoside, Madecassic Acid, Asiatic Acid, Caprylic/Capric Triglyceride, Mentha Aquatica Extract, Mentha Viridis (Spearmint) Extract, Origanum Vulgare Leaf Extract, 1,2-Hexanediol, Pistacia Lentiscus (Mastic) Gum, Hydrogenated Lecithin, Melissa Officinalis Extract, Pentylene Glycol, Totarol, Phenethyl Alcohol, Camellia Sinensis Leaf Extract, Mentha Rotundifolia Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Pinus Palustris Leaf Extract, Pueraria Lobata Root Extract, Ulmus Davidiana Root Extract, Ethylhexylglycerin
Other Safety Information
Protect the product in the container from excessive heat and direct sun
Package Label.Principal Display Panel
Image Description (Sunstick)
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