Active Ingredients
OCTINOXATE 7.5%
HOMOSALATE 6.0%
oCTISALATE 4.0%
aVOBENZONE 3.0%
Sunscreen With Moisturizer
FDA Label NDC 73110-106
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinclinical Ai, Llc for the product Sunscreen With Moisturizer (NDC 73110-106). 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 active ingredients, purpose, use, warnings, other information, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
Use
Helps prevent sunburn. If used with other sun protection measures (see Directions) decreases the chances of skin cancer and early signs of skin aging caused by the sun.
Warnings
For External Use Only. Do not use on damaged or broken skin.
When using this product keep away from eyes. If contact occurs, rinse with water to remove. Stop use and ask doctor if rash develops.
Other Information
Keep tightly closed. Protect from excessive heat (40°/140°F) and sun. May stain some fabrics.
Otc - Stop Use
Stop use and ask a doctor if irritation or sensitivity develops.
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
Apply generously 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating immediately after towel drying. Sun protection measures: Spending time in the sun increases your chances of skin cancer and early signs of aging. To decrease this risk, regularly use a sunscreen with SPF protection value 15 or higher and other sun protection measures including limited time in the sun, especially between the hours of 10am -2pm, wear long-sleeved shirt, pants, hat and sunglasses. Children under 6 months of age, consult a doctor before use.
Inactive Ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glycerin, Diethylhexyl 2,6-Naphthalate, Silica, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, PEG-12/SMDI Copolymer, Sorbitan Stearate, Phenoxyethanol, Ethylhexylglycerin, Xanthan Gum, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil
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