SKIN MEDICINALS SM CLEAR BROAD SPECTRUM SPF 50- zinc oxide, octinoxate cream

Skin Medicinals SM Clear Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Skin Medicinals SM Clear Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by SKIN MEDICINALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts FOR USA ONLY

Active Ingredient

Zinc Oxide - 9.0%

Octinoxate - 7.5%

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

Do not use

on damaged or broken skin

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

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.

Questions or Comments

call 312-535-9924

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.

Package Labelling:

INGREDIENTS AND APPEARANCE

SKIN MEDICINALS SM CLEAR BROAD SPECTRUM SPF 50 
zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85748-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NIACINAMIDE (UNII: 25X51I8RD4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85748-001-00	58 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2025

Labeler - SKIN MEDICINALS LLC (138391338)