SPL v1
SPL
SPL Set ID 48f13b1c-8104-881b-e063-6394a90a816d
Route
CUTANEOUS
Published
Effective Date 2026-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.85 g) Ethylhexyl Salicylate (3 g)
Inactive Ingredients
Iodopropynyl Butylcarbamate Sodium Chloride Sorbitan Oleate Water Isohexadecane Ethylhexyl Palmitate Polyglyceryl-3 Diisostearate Magnesium Stearate Alumina Diazolidinyl Urea Paraffinum Liquidum Polyglyceryl-2 Dipolyhydroxystearate Tocopherol Glycerin Propylene Glycol Triethoxycaprylylsilane Beeswax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-22

Description

WATER GLYCERIN ETHYLHEXYL PALMITATE ISOHEXADECANE PARAFFINUM LIQUIDUM POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE BEESWAX SORBITAN OLEATE SODIUM CHLORIDE POLYGLYCERYL-3 DIISOSTEARATE MAGNESIUM STEARATE TOCOPHEROL PROPYLENE GLYCOL DIAZOLIDINYL UREA TRIETHOXYCAPRYLYLSILANE ALUMINA IODOPROPYNYL BUTYLCARBAMATE


Medication Information

Warnings and Precautions



For external use only. Keep out of reach of children. Avoid contactwith eyes.Discontinue use if signs of irritation or rash occur,

Store in a cooand dry place.

Indications and Usage



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.

Dosage and Administration



Shake the contents thoroughly, apply appropriate amount to the palm, evenly apply to the face, neck, and body skin, and evenly pat

around until absorbed

Description

WATER GLYCERIN ETHYLHEXYL PALMITATE ISOHEXADECANE PARAFFINUM LIQUIDUM POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE BEESWAX SORBITAN OLEATE SODIUM CHLORIDE POLYGLYCERYL-3 DIISOSTEARATE MAGNESIUM STEARATE TOCOPHEROL PROPYLENE GLYCOL DIAZOLIDINYL UREA TRIETHOXYCAPRYLYLSILANE ALUMINA IODOPROPYNYL BUTYLCARBAMATE

Section 50565-1



Do not use on broken skin; avoid contact with eyes.lf product gets into eyes, rinseimmediately with plentyof water.Discontinue use if discomfort occurs

Section 51727-6

WATER

GLYCERIN

ETHYLHEXYL PALMITATE

ISOHEXADECANE

PARAFFINUM LIQUIDUM

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

BEESWAX

SORBITAN OLEATE

SODIUM CHLORIDE

POLYGLYCERYL-3 DIISOSTEARATE

MAGNESIUM STEARATE

TOCOPHEROL

PROPYLENE GLYCOL

DIAZOLIDINYL UREA

TRIETHOXYCAPRYLYLSILANE

ALUMINA

IODOPROPYNYL BUTYLCARBAMATE

Section 51945-4

Section 55105-1

Sun protection

Section 55106-9

TITANIUM DIOXIDE 2.85%

ETHYLHEXYL SALICYLATE 3%


Structured Label Content

Indications and Usage (34067-9)



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.

Dosage and Administration (34068-7)



Shake the contents thoroughly, apply appropriate amount to the palm, evenly apply to the face, neck, and body skin, and evenly pat

around until absorbed

Warnings and Precautions (34071-1)



For external use only. Keep out of reach of children. Avoid contactwith eyes.Discontinue use if signs of irritation or rash occur,

Store in a cooand dry place.

Section 50565-1 (50565-1)



Do not use on broken skin; avoid contact with eyes.lf product gets into eyes, rinseimmediately with plentyof water.Discontinue use if discomfort occurs

Section 51727-6 (51727-6)

WATER

GLYCERIN

ETHYLHEXYL PALMITATE

ISOHEXADECANE

PARAFFINUM LIQUIDUM

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

BEESWAX

SORBITAN OLEATE

SODIUM CHLORIDE

POLYGLYCERYL-3 DIISOSTEARATE

MAGNESIUM STEARATE

TOCOPHEROL

PROPYLENE GLYCOL

DIAZOLIDINYL UREA

TRIETHOXYCAPRYLYLSILANE

ALUMINA

IODOPROPYNYL BUTYLCARBAMATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sun protection

Section 55106-9 (55106-9)

TITANIUM DIOXIDE 2.85%

ETHYLHEXYL SALICYLATE 3%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)