SPL v1
SPL
SPL Set ID 3dba1360-f70f-e450-e063-6394a90a8c9f
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) Titanium Dioxide (0.11765 g) Octinoxate (0.04995 g) Homosalate (0.05 g)
Inactive Ingredients
Alumina Polyhydroxystearic Acid (2300 Mw) Tridecyl Trimellitate Phenyl Trimethicone Sodium Chloride Ci 77499 Ci 77491 Fragrance Lemon Orc2001060 Magnesium Sulfate Sodium Hydroxide Phenoxyethanol Silicon Dioxide Water Butylene Glycol Cyclopentasiloxane Ci 77492 Disteardimonium Hectorite C12-15 Alkyl Benzoate Polyglyceryl-3 Diisostearate Sorbitan Isostearate Polyglyceryl-2 Dipolyhydroxystearate Ethylhexylglycerin Glycerin Triethoxycaprylylsilane Bht Diisostearyl Malate

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, Phenyl Trimethicone, Butylene Glycol, Cyclopentasiloxane, Polyglyceryl-3 Diisostearate, Sorbitan Isostearate, Tridecyl Trimellitate, Diisostearyl Malate, Polyglyceryl-2 Dipolyhydroxystearate, Triethoxycaprylylsilane, Phenoxyethanol, Disteardimonium Hectorite, Alumina, Polyhydroxystearic Acid, Magnesium Sulfate, Sodium Chloride,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

Sunscreen

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, Phenyl Trimethicone, Butylene Glycol, Cyclopentasiloxane, Polyglyceryl-3 Diisostearate, Sorbitan Isostearate, Tridecyl Trimellitate, Diisostearyl Malate, Polyglyceryl-2 Dipolyhydroxystearate, Triethoxycaprylylsilane, Phenoxyethanol, Disteardimonium Hectorite, Alumina, Polyhydroxystearic Acid, Magnesium Sulfate, Sodium Chloride,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)

Sunscreen

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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