Otc - Active Ingredient
ACTIVE INGREDIENTS:
Avobenzone 3.00%
Homosalate 7.00%
Octisalate 5.00%
Sofie Pavitt Face Spf 30 Cream
FDA Label NDC 68577-234
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa., Corp for the product Sofie Pavitt Face Spf 30 (NDC 68577-234). 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, uses, warnings, 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
Otc - Purpose
Purpose
Sunscreen
Uses
Use
- Help 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
Warnings
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
- skin rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Directions
- Apply liberally and evenly15 minutes before sun exposure.
- Children under 6 months of age:Ask a doctor.
- SunProtectionMeasures. Spending time inthe sun increases your risk of skin cancer and early skin aging.To decrease this risk,regularty use a sunscreen with abroad spectrum SPFvalue of 15 or highe rand other sun protection measures including:
- limit your time in the sun,especially from 10a.m.-2p.m.
- wearlong-sleeved shirts,pants,hats,and sunglasses.
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
Other Safety Information
Other information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
Inactive Ingredients
Water, C12-15 Alkyl Benzoate,Glycerin, Butyloctyl Salicylate, Niacinamide, Propanediol, Pentylene Glycol Ectoin, Eugenia Caryophyllus (Clove) Bud Extract,Solidago Virgaurea (Goldenrod) Extract, Allantoin, Bisabolol, Tocopheryl Acetate, lnulin lauryl Carbamate, Sodium Polyacryloyldimethyl Taurate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum,Silica,Ethylhexyl Methoxycrylene, 1,2-Hexanediol,Citric Acid,Ethylhexylglycerin, Phenoxyethanol.
Package Label.Principal Display Panel
NDC 6877-234
Tube (Sofie Pp10ml)
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