SPL v1
SPL
SPL Set ID 400611c9-c89d-4168-e063-6394a90a82dc
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (3.75 g) Octocrylene (6 g) Octinoxate (3 g)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-30

Description

OCTOCRYLENE HOMOSALATE OCTINOXATE

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

OCTOCRYLENE HOMOSALATE OCTINOXATE

Uses

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.

Section 51945-4

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

OCTOCRYLENE

HOMOSALATE

OCTINOXATE

Inactive Ingredients

Water

Glycerin

C12-15 Alkyl Benzoate

Dimethicone

Isododecane

Butyloctyl Salicylate

Propanediol

Stearic Acid

PEG-100 Stearate

Sorbitan Stearate

Niacinamide

Ceramide NP

Ceramide AP

Ceramide EOP

Sorbitan Isostearate

Carbomer

Cetearyl Alcohol

Ceteareth-20

Triethoxycaprylylsilane

Dimethiconol

Sodium Citrate

Sodium Lauroyl Lactylate

Sodium Dodecylbenzenesulfonate

Myristic Acid

Sodium Hyaluronate

Cholesterol

Aluminum Hydroxide

Palmitic Acid

Phenoxyethanol

Chlorphenesin

Hydroxyethyl Acrylate / Sodium Acryloyldimethyl Taurate Copolymer

Caprylyl Glycol

Citric Acid

Panthenol

Xanthan Gum

Phytosphingosine

Polyhydroxystearic Acid

Polysorbate 60

Ethylhexylglycerin

Dosage & Administration

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Uses

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.

Section 51945-4 (51945-4)

Purpose

SUNSCREEN

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

OCTOCRYLENE

HOMOSALATE

OCTINOXATE

Inactive Ingredients (Inactive ingredients)

Water

Glycerin

C12-15 Alkyl Benzoate

Dimethicone

Isododecane

Butyloctyl Salicylate

Propanediol

Stearic Acid

PEG-100 Stearate

Sorbitan Stearate

Niacinamide

Ceramide NP

Ceramide AP

Ceramide EOP

Sorbitan Isostearate

Carbomer

Cetearyl Alcohol

Ceteareth-20

Triethoxycaprylylsilane

Dimethiconol

Sodium Citrate

Sodium Lauroyl Lactylate

Sodium Dodecylbenzenesulfonate

Myristic Acid

Sodium Hyaluronate

Cholesterol

Aluminum Hydroxide

Palmitic Acid

Phenoxyethanol

Chlorphenesin

Hydroxyethyl Acrylate / Sodium Acryloyldimethyl Taurate Copolymer

Caprylyl Glycol

Citric Acid

Panthenol

Xanthan Gum

Phytosphingosine

Polyhydroxystearic Acid

Polysorbate 60

Ethylhexylglycerin

Dosage & Administration (Dosage & administration)

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep Out Of Reach Of Children


Advanced Ingredient Data


Raw Label Data

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