SPL v1
SPL
SPL Set ID 47df072e-151f-eb30-e063-6294a90a4eeb
Route
TOPICAL
Published
Effective Date 2026-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (16.2 g) Avobenzone (5.4 g) Octisalate (7.2 g) Octocrylene (9 g)
Inactive Ingredients
C14-22 Alcohols Butylene Glycol Chlorphenesin Aloe Barbadensis Leaf Powder Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Trehalose Silica Steareth-21 Sorbitan Isostearate Panthenol C12-20 Alkyl Glucoside Edetate Disodium Water Polysorbate 60 Butyloctyl Salicylate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-08

Description

OCTOCRYLENE OCTISALATE AVOBENZONE HOMOSALATE


Medication Information

Warnings and Precautions

For external use only .

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes . Rinse with water to remove .

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away .

Indications and Usage

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on

moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor..

Description

OCTOCRYLENE OCTISALATE AVOBENZONE HOMOSALATE

Section 50565-1

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away

Section 51727-6

BUTYLENE GLYCOL

WATER

C14-22 ALCOHOLS

C12-20 ALKYL GLUCOSIDE

BUTYLOCTYL SALICYLATE

STEARETH-21

HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

POLYSORBATE 60

SORBITAN ISOSTEARATE

TREHALOSE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

PHENOXYETHANOL

CHLORPHENESIN

FRAGRANCE

DISODIUM EDTA

PANTHENOL

ALOE BARBADENSIS LEAF WATER

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

OCTOCRYLENE

OCTISALATE

AVOBENZONE

HOMOSALATE


Structured Label Content

Indications and Usage (34067-9)

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on

moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor..

Warnings and Precautions (34071-1)

For external use only .

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes . Rinse with water to remove .

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)

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away

Section 51727-6 (51727-6)

BUTYLENE GLYCOL

WATER

C14-22 ALCOHOLS

C12-20 ALKYL GLUCOSIDE

BUTYLOCTYL SALICYLATE

STEARETH-21

HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

POLYSORBATE 60

SORBITAN ISOSTEARATE

TREHALOSE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

PHENOXYETHANOL

CHLORPHENESIN

FRAGRANCE

DISODIUM EDTA

PANTHENOL

ALOE BARBADENSIS LEAF WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

OCTOCRYLENE

OCTISALATE

AVOBENZONE

HOMOSALATE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)