SPL v1
SPL
SPL Set ID 3cdc1ae9-2924-5057-e063-6294a90ad2f3
Route
TOPICAL
Published
Effective Date 2025-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (0.02 g) Octinoxate (0.04995 g) Titanium Dioxide (0.11765 g) Homosalate (0.05 g)
Inactive Ingredients
C12-15 Alkyl Benzoate Cyclopentasiloxane Polyglyceryl-3 Diisostearate Phenoxyethanol Disteardimonium Hectorite Triethoxycaprylylsilane Alumina Magnesium Sulfate Sodium Hydroxide Phenyl Trimethicone Water Ethylhexylglycerin Sorbitan Isostearate Polyhydroxystearic Acid (2300 Mw) Ci 77491 Bht Butylene Glycol Ci 77492 Polyglyceryl-2 Dipolyhydroxystearate Glycerin Fragrance Lemon Orc2001060 Silicon Dioxide Ci 77499 Diisostearyl Malate Tridecyl Trimellitate Sodium Chloride

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-30

Description

Ensulizole 2%,Homosalate 5%,Octinoxate 4.995%,Titanium Dioxide 11.765%


Medication Information

Warnings and Precautions

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 lf

rash or irritation develops and lasts

keep out of reach of children.

if product is swallowed,get medical help or contact a poison control center right away.

Indications and Usage

helps prevent sunburn

provides high protection against sunburn and tanning

lf used as directed with other sun protection measures.

decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and Administration

For sunscreen use:

apply liberally 15 minutes before sun exposure

reapply at least every two hours

use a water resistant sunscreen if swimming or sweating

wear long-sleeved shirts, pants, hats and sunglasses

children under 6 months :Ask a doctor

Description

Ensulizole 2%,Homosalate 5%,Octinoxate 4.995%,Titanium Dioxide 11.765%

Section 50565-1

if product is swallowed,get medical help or contact a poison control center right away.

Section 51727-6

Water, Glycerin,Silica, C12-15 Alkyl Benzoate, PhenylTrimethicone,Butylene Glycol, Cyclopentasiloxane,Polyglyceryl-3 Diisostearate, Sorbitan lsostearate, Tridecyl Trimellitate,Diisostearyl Malate,Polyglyceryl-2 Dipolyhydroxystearate, Triethoxycaprylylsilane, Phenoxyethanol,Disteardimonium Hectorite,Alumina, Polyhydroxystearic Acid, Magnesium Sulfate, Sodium Chloride,Sodium Hydroxide, Fragrance, Ethylhexylglycerin, BHT,lron Oxides(Cl77492,C177491,C177499)

Section 51945-4

Section 55105-1

Suncreen

Section 55106-9

Ensulizole 2%,Homosalate 5%,Octinoxate 4.995%,Titanium Dioxide 11.765%

Section 60561-8

protect the product in this container from excessive

heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

helps prevent sunburn

provides high protection against sunburn and tanning

lf used as directed with other sun protection measures.

decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and Administration (34068-7)

For sunscreen use:

apply liberally 15 minutes before sun exposure

reapply at least every two hours

use a water resistant sunscreen if swimming or sweating

wear long-sleeved shirts, pants, hats and sunglasses

children under 6 months :Ask a doctor

Warnings and Precautions (34071-1)

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 lf

rash or irritation develops and lasts

keep out of reach of children.

if product is swallowed,get medical help or contact a poison control center right away.

Section 50565-1 (50565-1)

if product is swallowed,get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, Glycerin,Silica, C12-15 Alkyl Benzoate, PhenylTrimethicone,Butylene Glycol, Cyclopentasiloxane,Polyglyceryl-3 Diisostearate, Sorbitan lsostearate, Tridecyl Trimellitate,Diisostearyl Malate,Polyglyceryl-2 Dipolyhydroxystearate, Triethoxycaprylylsilane, Phenoxyethanol,Disteardimonium Hectorite,Alumina, Polyhydroxystearic Acid, Magnesium Sulfate, Sodium Chloride,Sodium Hydroxide, Fragrance, Ethylhexylglycerin, BHT,lron Oxides(Cl77492,C177491,C177499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Suncreen

Section 55106-9 (55106-9)

Ensulizole 2%,Homosalate 5%,Octinoxate 4.995%,Titanium Dioxide 11.765%

Section 60561-8 (60561-8)

protect the product in this container from excessive

heat and direct sun


Advanced Ingredient Data


Raw Label Data

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