Safeguard Spf 40 Cream
FDA Label NDC 83578-205

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skinsalvation Skincare, Inc. for the product Safeguard Spf 40 (NDC 83578-205). 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 ingredient, 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

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

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

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 product is swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply: - after 40 minutes of swimming or sweating - immediately after towel drying - at least every two hours
  • 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 of 15 or higher and other skin protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
    • Children under 6 months: ask a doctor

Inactive Ingredients

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/ PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/ Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • For easier application, dispense onto and rub between fingertips to warm before applying.

Questions Or Comments?

made for with & within by skinsalvation skincare inc.

san francisco, ca 94109 | withandwithin.co

Principal Display Panel – 100 G Tube Label

with &
within

safeguard
SPF 40

clear skin for everyone

FACE
& BODY

broad spectrum spf 40

water resistant (40 minutes)

Net wt. 3.5 oz / 100 g

Principal Display Panel – 100 G Tube Label (Saf1c 0000 01)

Principal Display Panel – 100 G Tube Label (Saf1c 0000 01)

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