Otc - Active Ingredient
Active ingredients Purpose
OCTINOXATE 7.5% sunscreen
OCTISALATE 5.0% sunscreen
Foundation Primer Plus Spf 15 Cream
FDA Label NDC 57627-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Merle Norman Cosmetics, Inc for the product Foundation Primer Plus Spf 15 (NDC 57627-108). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, 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
Uses Helps Prevent Sunburn
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.
Indications & Usage
Stop use and ask a doctor if rash occurs and persists
Warnings
Warnings
Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin canceror early skin aging.
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.
Dosage & Administration
Directions
For Sunscreen use:
Apply Liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients
Cyclopentasiloxane, Dimethicone Crosspolymer, Trisiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cyclomethicone, Palmitoyl Oligopeptide, Ascorbyl Palmitate, Retinyl Palmitate, Tocopheryl Acetate, Ceramide 2 , Camellia Oleifera Leaf Extract, PEG-10 Rapeseed Sterol, Phospholipids, C12-15 Alkyl Benzoate, Cyclotetrasiloxane, Water (Aqua), Isoceteth-10, Tribehenin, Butylene Glycol, Silica, Phenoxyethanol.
Package Label.Principal Display Panel
Foundation Primer Plus
SPF 15
Merle Norman
35g Net Wt. 1.25 OZ
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