4931ee71-1088-1ac1-e063-6294a90ad82b

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.

Active Ingredient

HOMOSALATE

OCTOCRYLENE

OCTISALATE

AVOBENZONE

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


Structured Label Content

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.

Active Ingredient (55106-9)

HOMOSALATE

OCTOCRYLENE

OCTISALATE

AVOBENZONE

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

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


Advanced Ingredient Data


Raw Label Data

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