Package Label.Principal Display Panel
50ml Label (7758 Usrx Compexion Protection Moisturizer Label 1.7oz Fa5 New 091721)
Complexion Protection Moisturizer Spf
FDA Label NDC 70809-1912
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Usrx Llc for the product Complexion Protection Moisturizer Spf (NDC 70809-1912). 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 package label.principal display panel, active ingredients, purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octisalate (Ethylhexyl Salicylate) 5%
Zinc Oxide 11.6%
Purpose
Sunscreen
Uses
- helps prevent sunburn
- if used as directed with ohter sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove
Otc - Stop Use
Stop use and ask a doctor if rash occurs
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.
Warnings
For external use only
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear lon-sleeved shirts, pants, hats and sunglasses
- Children under 6 months of age:Ask a doctor
Other Information
- protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Propanediol, Tetradecane, Butyloctyl Salicylate,
C12-15 Alkyl Benzoate, Polyester-8, Cetearyl Olivate, Glycerin, Lauroyl Lysine, Silica,
Polyhydroxystearic Acid, Glyceryl Stearate Citrate, Niacinamide, Pentylene Glycol,
Potassium Cetyl Phosphate, Sorbitan Olivate, Inulin Lauryl Carbamate, 1,2-Hexanediol,
Hydroxyacetophenone, Squalane, Diethylhexyl Syringylidenemalonate, Cetearyl Alcohol,
Acacia Senegal Gum, Lactic Acid, Xanthan Gum, Sodium Stearoyl Glutamate,
Chlorphenesin, Coco-Glucoside, Trisodium Ethylenediamine Disuccinate, Tocopheryl
Acetate (Vitamin E), Tridecane, Sodium Citrate, C13-14 Allkane, Cucumis Sativus
(Cucumber) Fruit Extract, Sodium Hyaluronate, Ascorbic Acid (Vitamin C)
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