SPL v2
SPL
SPL Set ID 3dbb07e2-971c-284d-e063-6294a90a437f
Route
TOPICAL
Published
Effective Date 2025-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.10725 g) Ensulizole (0.02 g) Homosalate (0.05 g) Octinoxate (0.04995 g)
Inactive Ingredients
Sodium Hydroxide Fragrance Lemon Orc2001060 Butylene Glycol Bht Polyhydroxystearic Acid (2300 Mw) Magnesium Sulfate Silicon Dioxide Tridecyl Trimellitate Ethylhexylglycerin Sorbitan Isostearate Water Cyclopentasiloxane Ci 77492 C12-15 Alkyl Benzoate Alumina Phenyl Trimethicone Polyglyceryl-3 Diisostearate Disteardimonium Hectorite Glycerin Diisostearyl Malate Polyglyceryl-2 Dipolyhydroxystearate Sodium Chloride Ci 77499 Phenoxyethanol Ci 77491 Triethoxycaprylylsilane

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 10.725%


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 10.725%

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, Phenyl Trimethicone, Butylene Glycol, Cyclopentasiloxane, Polyglyceryl-3 Diisostearate, Sorbitan Isostearate, Tridecyl Trimellitate, Diisostearyl Malate, Polyglyceryl-2 Dipolyhydroxystearate,Phenoxyethanol, Triethoxycaprylylsilane, Disteardimonium Hectorite, Polyhydroxystearic Acid, Magnesium Sulfate, Sodium Chloride, Alumina,Sodium Hydroxide, Fragrance, Ethylhexylglycerin, BHT,Iron Oxides(CI 77492,CI 77491,CI 77499)

Section 51945-4

Section 53413-1

Call 1-818-579-72880 or 1-818-688-3208

WWW.PHOFAY.COM

Section 55105-1

Suncreen

Section 55106-9

Ensulizole 2%,Homosalate 5%,Octinoxate 4.995%,Titanium Dioxide 10.725%

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, Phenyl Trimethicone, Butylene Glycol, Cyclopentasiloxane, Polyglyceryl-3 Diisostearate, Sorbitan Isostearate, Tridecyl Trimellitate, Diisostearyl Malate, Polyglyceryl-2 Dipolyhydroxystearate,Phenoxyethanol, Triethoxycaprylylsilane, Disteardimonium Hectorite, Polyhydroxystearic Acid, Magnesium Sulfate, Sodium Chloride, Alumina,Sodium Hydroxide, Fragrance, Ethylhexylglycerin, BHT,Iron Oxides(CI 77492,CI 77491,CI 77499)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 1-818-579-72880 or 1-818-688-3208

WWW.PHOFAY.COM

Section 55105-1 (55105-1)

Suncreen

Section 55106-9 (55106-9)

Ensulizole 2%,Homosalate 5%,Octinoxate 4.995%,Titanium Dioxide 10.725%

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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