SPL v1
SPL
SPL Set ID 4931ee71-1088-1ac1-e063-6294a90ad82b
Route
TOPICAL
Published
Effective Date 2026-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (6 g) Octisalate (5 g) Avobenzone (3 g) Homosalate (7 g)
Inactive Ingredients
Sodium Hyaluronate Propylene Glycol Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Magnesium Stearate Phenoxyethanol Chlorphenesin Sodium Acetylated Hyaluronate Magnesium Sulfate Caprylic/capric Triglyceride Sodium Hyaluronate Crosspolymer-6 Niacinamide Aluminum Starch Octenylsuccinate Cetyl Peg/ppg-10/1 Dimethicone (hlb 3.7) Tridecyl Trimellitate Ethylhexylglycerin Pentylene Glycol Cetyl Ethylhexanoate Xanthan Gum Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-25

Description

HOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONE


Medication Information

Warnings and Precautions

Warnings+For external use only.Do not use on damaged or broken skin..Keep out of eyes. Rinse with water to remove if contactis made.

.Stop use and ask a doctor if rash occurs.

.Keep out of reach of children,If swallowed,get medical help or contact a Poison Control Center right away.*Flammable.Do not spray near heat sparks,sources ofignition, or flames,.If irritation develops.discontinue use and consult a doctor.

Indications and Usage

+Use a water resistant sunscreen if swimming or sweating.Sun Protection Messures,Spending ime in the sun increases yourisk of skin cane nd eary skin aging. To decrease this isk,regudarlyuse a sunscreen with broad spectrum SPF of15 or higher and other sun protection measures including: Limit time in the sun,especially from 10 a.m,-2 p.m.

* Wear long-sleeve shints,pants,hats,and sunglasses*Children under 6 months: Ask a doctor

Dosage and Administration



*Apply generously and evenly 15 minutes before sun exposure+Reapplv at least everv 2 hours

Description

HOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONE

Section 50565-1

Keep out of reach of children, If swallowed,get medical help or contact a Poison Controf Center right away

Section 51727-6

WATER

GLYCERIN

CAPRYLIC/CAPRIC TRIGLYCERIDE

TRIDECYL TRIMELLITATE

PROPYLENE GLYCOL

CETYL ETHYLHEXANOATE

ALUMINUM STARCH OCTENYLSUCCINATE

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

MAGNESIUM SULFATE

MAGNESIUM STEARATE

CETYL PEG/PPG-10/1 DIMETHICONE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

CHLORPHENESIN

XANTHAN GUM

3-o-ETHYL ASCORBIC ACID

NIACINAMIDE

PENTYLENE GLYCOL

SODIUM HYALURONATE

SODIUM ACETYLATED HYALURONATE

SODIUM HYALURONATE CROSSPOLYMER

HYDROLYZED SODIUM HYALURONATE

ETHYLHEXYLGLYCERIN

Section 51945-4

Section 55105-1

.Helps prevent sunbum

.If used as directed with other sun protection measures (see Directions), decreases the riskof skin cancer and early skin aging caused by the sun

Section 55106-9

HOMOSALATE

OCTOCRYLENE

OCTISALATE

AVOBENZONE


Structured Label Content

Indications and Usage (34067-9)

+Use a water resistant sunscreen if swimming or sweating.Sun Protection Messures,Spending ime in the sun increases yourisk of skin cane nd eary skin aging. To decrease this isk,regudarlyuse a sunscreen with broad spectrum SPF of15 or higher and other sun protection measures including: Limit time in the sun,especially from 10 a.m,-2 p.m.

* Wear long-sleeve shints,pants,hats,and sunglasses*Children under 6 months: Ask a doctor

Dosage and Administration (34068-7)



*Apply generously and evenly 15 minutes before sun exposure+Reapplv at least everv 2 hours

Warnings and Precautions (34071-1)

Warnings+For external use only.Do not use on damaged or broken skin..Keep out of eyes. Rinse with water to remove if contactis made.

.Stop use and ask a doctor if rash occurs.

.Keep out of reach of children,If swallowed,get medical help or contact a Poison Control Center right away.*Flammable.Do not spray near heat sparks,sources ofignition, or flames,.If irritation develops.discontinue use and consult a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children, If swallowed,get medical help or contact a Poison Controf Center right away

Section 51727-6 (51727-6)

WATER

GLYCERIN

CAPRYLIC/CAPRIC TRIGLYCERIDE

TRIDECYL TRIMELLITATE

PROPYLENE GLYCOL

CETYL ETHYLHEXANOATE

ALUMINUM STARCH OCTENYLSUCCINATE

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

MAGNESIUM SULFATE

MAGNESIUM STEARATE

CETYL PEG/PPG-10/1 DIMETHICONE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

CHLORPHENESIN

XANTHAN GUM

3-o-ETHYL ASCORBIC ACID

NIACINAMIDE

PENTYLENE GLYCOL

SODIUM HYALURONATE

SODIUM ACETYLATED HYALURONATE

SODIUM HYALURONATE CROSSPOLYMER

HYDROLYZED SODIUM HYALURONATE

ETHYLHEXYLGLYCERIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

.Helps prevent sunbum

.If used as directed with other sun protection measures (see Directions), decreases the riskof skin cancer and early skin aging caused by the sun

Section 55106-9 (55106-9)

HOMOSALATE

OCTOCRYLENE

OCTISALATE

AVOBENZONE


Advanced Ingredient Data


Raw Label Data

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