skin medicinals sm clear broad spectrum spf 50

skin medicinals sm clear broad spectrum spf 50
SPL v1
SPL
SPL Set ID 364e9bac-85c4-afbd-e063-6394a90aba82
Route
topical
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (90 mg) octinoxate (75 mg)
Inactive Ingredients
water cyclomethicone 5 niacinamide neopentyl glycol diheptanoate butylene glycol potassium cetyl phosphate silicon dioxide phenoxyethanol triethoxycaprylylsilane lactic acid, unspecified form hyaluronate sodium peg-7 trimethylolpropane coconut ether ethylhexylglycerin sorbitan isostearate butylated hydroxytoluene

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-01

Purpose

Sunscreen

Description

Zinc Oxide - 9.0% Octinoxate - 7.5%


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 80 minutes of swimming or sweating
  • immediatelyafter towel drying
  • at least every 2 hours
  • Sun protectlon MeasuresSpending time In the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including
  • limit time in the sun, especially from 10 am-2pm
  • wear Long-sleeve shirts, parts, hats, and sunglasses
  • children under month Ask a doctor
Other Information

"Protect the product In this container from excessive heat or direct sun.

Inactive Ingredients

Water, Cyclopentasiloxane, Niacinamide, Neopentyl Glycol Diheptanoate, Butylene Glycol, Potassium Cetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Silica, Phenoxyethanol, Triethoxycaprylylsilane, Polyisobutene, Lactic Acid Sodium Hyaluronate, PEG-7 Trimethylolpropane Coconut Ether, Ethylhexylglycerin, Sorbitan Isostearate, BHT.

Description

Zinc Oxide - 9.0% Octinoxate - 7.5%

Do Not Use

on damaged or broken skin

Drug Facts 

Active Ingredient

Zinc Oxide - 9.0%

Octinoxate - 7.5%

Package Labelling:

Questions Or Comments

call 312-535-9924

When Using This Product

keep out of eyes. Rinse with water to remove 

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses (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 80 minutes of swimming or sweating
  • immediatelyafter towel drying
  • at least every 2 hours
  • Sun protectlon MeasuresSpending time In the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including
  • limit time in the sun, especially from 10 am-2pm
  • wear Long-sleeve shirts, parts, hats, and sunglasses
  • children under month Ask a doctor
Other Information

"Protect the product In this container from excessive heat or direct sun.

Inactive Ingredients

Water, Cyclopentasiloxane, Niacinamide, Neopentyl Glycol Diheptanoate, Butylene Glycol, Potassium Cetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Silica, Phenoxyethanol, Triethoxycaprylylsilane, Polyisobutene, Lactic Acid Sodium Hyaluronate, PEG-7 Trimethylolpropane Coconut Ether, Ethylhexylglycerin, Sorbitan Isostearate, BHT.

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts 

Active Ingredient

Zinc Oxide - 9.0%

Octinoxate - 7.5%

Package Labelling:

Questions Or Comments (Questions or Comments)

call 312-535-9924

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove 

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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


Advanced Ingredient Data


Raw Label Data

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