Resist Wrinkle Defense Spf 30 Cream
FDA Label NDC 56152-5003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Enterprises Ltd for the product Resist Wrinkle Defense Spf 30 (NDC 56152-5003). 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 and precautions, 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 - Active Ingredient

Active Ingredients                  Purpose

Zinc Oxide 13.0% .................  Sunscreen

Otc - Purpose

Uses

  • Helps prevent sunburn
  • If used as directed with otehr sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

Warnings And Precautions

Warnings

  • For external use only
  • When using this product keep out of eyes. Rinse with water to remove

Dosage & Administration

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or seating:
  •        Immediately after towel dyring
  •        At least every two hours
  • Children under 6 months of age: Ask a doctor

    • Sun ProtectionMeasures. 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 of 15 or higher and other sun protection measures, including:

    • Limit tim in the sun, especially from 10a.m.-2p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses 

Inactive Ingredient

Water (Aqua), Cyclopentasiloxane, PEG-12 Dimethicone, PEG/PPG-18/18 Dimethicone, Lauroyl Lysine, Sodium Chloride, Trihydroxystearin, Dimethicone Crosspolymer, Resveratrol, Quercetin, Epigalloactechin Gallate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Adenosine, Bisabolol, Salix Alba (Willow) Bark Extract, Punica Granatum (Pomegranate) Extract, Haematococus Pluvialis Extract, Hydrolyzed Corn Starch, Polysorbate 80, Hydrated Silica, Triethoxycaprylylsilane, C12-15 Alkyl Benzoate, Isopropyl Titanium Triisostearate, Hexylene Glycol, Ethylhexylglycerin, Iron Oxide (CI 77491, CI 77492, CI 77499), Caprylyl Glycol, Phenoxyethanol

Package Label.Principal Display Panel

PAULA'S CHOICE

RESIST

Super-Light Daily

Wrinkle Defense

Broad Spectrum SPF 30

60 ml / 2 fl. oz.

Image Description (7760 Component)

Image Description (7760 Component)

* Please review the disclaimer below.