Otc - Active Ingredient
Ethylhexyl Methoxycinnamate 7.00%
Titanium Dioxide 4.11%
Zinc Oxide 4.93%
Makeup Sun Primer
FDA Label NDC 70117-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Stw Enterprise Inc. for the product Makeup Sun Primer (NDC 70117-001). 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, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
Dosage & Administration
Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
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 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.
Inactive Ingredient
Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Silica, Triethylhexanoin, Phenethyl Benzoate, Butyrospermum Parkii (Shea) Butter, Bis-Ethylhexyloxyphenol MethoxyphenylTriazine, Dimethicone/Vinyl Dimethicone Crosspolymer, Ceresin, Cholesteryl Isostearate, Trimethylsiloxysilicate, PEG-10 Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Citrus Grandis (Grapefruit) Peel Oil, Ocimum Basilicum (Basil) Oil, Geranium Maculatum Oil, Propylene Glycol, Hydroxypropyl Bisstearamide MEA, Macadamia Integrifolia Seed Oil, Butylene Glycol, Argania Spinosa Kernel Oil, Dipropylene Glycol, Behenyl Alcohol, Ceteareth-20, Cholesterol, Cetearyl Alcohol, Squalane, Tricaprin
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