Active Ingredients
Avobenzone 2%
Octinoxate 7.5%
Octisalate 5%
Retexturizing Primer Broad Spectrum Spf 20 Cream
FDA Label NDC 59735-800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pml Nyc, Llc for the product Retexturizing Primer Broad Spectrum Spf 20 (NDC 59735-800). 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, uses, warnings, directions, other information, inactive ingredients, indications & usage, recent major changes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Helps 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
- 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.
Directions
- 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 risk of skin cancer and early 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:
- wear long sleeved shirts, pants, hats and sunglasses.
- Children under 6 months of age: ask a doctor.
limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Cyclopentasiloxane, Dimethicone Crosspolymer, Polysilicone-11, C12-15 Alkyl Benzoate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Laureth-12, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Salicylic Acid, Mica, Silica, Phenoxyethanol, Titanium Dioxide
Indications & Usage
Stop use and ask a doctor if rash occurs.
Recent Major Changes
dosage & admin update
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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Retexturizing Primer Spf (Img 7792rp3)
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