drug facts

drug facts
SPL v2
SPL
SPL Set ID 4730721b-6148-4a80-a749-13c4febf2e38
Route
topical
Published
Effective Date 2023-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (200 mg)
Inactive Ingredients
alkyl (c12-15) benzoate caprylhydroxamic acid caprylyl glycol cetyl peg/ppg-10/1 dimethicone (hlb 5) cyclomethicone 6 cyclomethicone 5 dimethicone 100 dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) dimethicone/vinyl dimethicone crosspolymer (soft particle) dimethiconol (2000 cst) edetate disodium glycerin hydrogen dimethicone (20 cst) microcrystalline wax peg-10 dimethicone (600 cst) peg-30 dipolyhydroxystearate (4000 mw) polyglyceryl-4 isostearate polyhydroxystearic acid (2300 mw) polysorbate 20 sodium chloride stearyl dimethicone (400 mpa.s at 50c) tetrahexyldecyl ascorbate .alpha.-tocopherol acetate trolamine triethoxycaprylylsilane water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-06-30
Purpose

Sunscreen

Description

Zinc Oxide 20%

Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

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
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.
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

Description

Zinc Oxide 20%

Section 50565-1
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9
  • Stop use and ask a doctor if rash occurs
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin
Active Ingredient

Zinc Oxide 20%

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

Structured Label Content

Warnings

For external use only

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
Purpose (PURPOSE)

Sunscreen

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
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.
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

Section 50565-1 (50565-1)
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Active Ingredient

Zinc Oxide 20%

Questions Or Comments? (Questions or Comments?)

made for with & within by skinsalvation skincare inc.

san francisco, ca 94109 | withandwithin.co

Principal Display Panel – 100 G Tube Label (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.944973 · Updated: 2026-03-14T23:07:03.829205