85885-121

Drug Facts

Composition & Product

Active Ingredients

octisalate (5 g) homosalate (7 g) octocrylene (9 g) avobenzone (3 g)

Inactive Ingredients

isododecane isohexadecane dimethicone/vinyl dimethicone crosspolymer (soft particle) tocopherol dimethicone/bis-isobutyl ppg-20 crosspolymer

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-07-11

Medication Information

Warnings and Precautions

WarningsFor extemal use only, Do not use on damaged or broken skin.When using this product: keep out of eyes. Rinse withwater to remove.Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away. UVexposure from the sun increases the risk of skin cancer,premature skin aging, and other skin damage. lt isimportant to decrease UV exposure by limiting time inthe sun, wearing protective clothing, and using asunscreen.

Indications and Usage

Directions

Apply liberally 15 minutes before sun exposure..Reapply: at least every 2 hours. After 40 or 80 minutesof swimming or sweating.lmmediately after toweldrying..Sun Protection Measures: Spending time in the sunincreases your risk of skin cancer and early skin agingTo decrease this risk, regularly use a sunscreen with aBroad Spectrum SPF of 15 or higher and othEr sunprotection measures including: limit time in sun,especially from 10 a.m.-2 p.m., and wear long-sleevedshirts, pants, hats and sunglasses. Children under 6months of age: ask a doctor.

Dosage and Administration

Apply liberally 15 minutes before sun exposure.Reapply: at least every 2 hours. After 40 or 80 minutesof swimming or sweating. lmmediately after toweldrying.

Description

Octocrylene Homosalate Octisalate Avobenzone

Section 50565-1

Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away. UVexposure from the sun increases the risk of skin cancerpremature skin aging, and other skin damage. lt isimportant to decrease UV exposure by limiting time inthe sun, wearing protective clothing, and using asunscreen.

Section 50567-7

Uses

Helps prevent sunburn.If used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer andearly skin aging caused by the sun.

Section 51727-6

Isohexadecane, Dimethicone/Vinyl DimethiconeCrosspolymer, lsododecane, Dimethicone/Bis-sobutyPpg20 Crosspolymer, Tocopherol

Section 51945-4

Section 55105-1

Sunscreen

Section 60561-8

Other information

Protect this product in this container from excessiveheat and direct sun.

Active Ingrendient

Octocrylene

Homosalate

Octisalate

Avobenzone

Structured Label Content

Warnings and Precautions (34071-1)

WarningsFor extemal use only, Do not use on damaged or broken skin.When using this product: keep out of eyes. Rinse withwater to remove.Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away. UVexposure from the sun increases the risk of skin cancer,premature skin aging, and other skin damage. lt isimportant to decrease UV exposure by limiting time inthe sun, wearing protective clothing, and using asunscreen.

Indications and Usage (34067-9)

Directions

Apply liberally 15 minutes before sun exposure..Reapply: at least every 2 hours. After 40 or 80 minutesof swimming or sweating.lmmediately after toweldrying..Sun Protection Measures: Spending time in the sunincreases your risk of skin cancer and early skin agingTo decrease this risk, regularly use a sunscreen with aBroad Spectrum SPF of 15 or higher and othEr sunprotection measures including: limit time in sun,especially from 10 a.m.-2 p.m., and wear long-sleevedshirts, pants, hats and sunglasses. Children under 6months of age: ask a doctor.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure.Reapply: at least every 2 hours. After 40 or 80 minutesof swimming or sweating. lmmediately after toweldrying.

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away. UVexposure from the sun increases the risk of skin cancerpremature skin aging, and other skin damage. lt isimportant to decrease UV exposure by limiting time inthe sun, wearing protective clothing, and using asunscreen.

Section 50567-7 (50567-7)

Uses

Helps prevent sunburn.If used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer andearly skin aging caused by the sun.

Section 51727-6 (51727-6)

Isohexadecane, Dimethicone/Vinyl DimethiconeCrosspolymer, lsododecane, Dimethicone/Bis-sobutyPpg20 Crosspolymer, Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

Other information

Protect this product in this container from excessiveheat and direct sun.

Active Ingrendient (ACTIVE INGRENDIENT)

Octocrylene

Homosalate

Octisalate

Avobenzone

Advanced Ingredient Data

[{"name": "ISODODECANE", "unii": "A8289P68Y2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOHEXADECANE", "unii": "918X1OUF1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)", "unii": "9E4CO0W6C5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER", "unii": "O4I3UFO6ZF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "9", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions Apply liberally 15 minutes before sun exposure..Reapply: at least every 2 hours. After 40 or 80 minutesof swimming or sweating.lmmediately after toweldrying..Sun Protection Measures: Spending time in the sunincreases your risk of skin cancer and early skin agingTo decrease this risk, regularly use a sunscreen with aBroad Spectrum SPF of 15 or higher and othEr sunprotection measures including: limit time in sun,especially from 10 a.m.-2 p.m., and wear long-sleevedshirts, pants, hats and sunglasses. Children under 6months of age: ask a doctor.", "34068-7": "Apply liberally 15 minutes before sun exposure.Reapply: at least every 2 hours. After 40 or 80 minutesof swimming or sweating. lmmediately after toweldrying.", "34071-1": "WarningsFor extemal use only, Do not use on damaged or broken skin.When using this product: keep out of eyes. Rinse withwater to remove.Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away. UVexposure from the sun increases the risk of skin cancer,premature skin aging, and other skin damage. lt isimportant to decrease UV exposure by limiting time inthe sun, wearing protective clothing, and using asunscreen.", "50565-1": "Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf swallowed, get medicalhelp or contact a Poison Control Center right away. UVexposure from the sun increases the risk of skin cancerpremature skin aging, and other skin damage. lt isimportant to decrease UV exposure by limiting time inthe sun, wearing protective clothing, and using asunscreen.", "50567-7": "Uses Helps prevent sunburn.If used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer andearly skin aging caused by the sun.", "51727-6": "Isohexadecane, Dimethicone/Vinyl DimethiconeCrosspolymer, lsododecane, Dimethicone/Bis-sobutyPpg20 Crosspolymer, Tocopherol", "55105-1": "Sunscreen", "60561-8": "Other information Protect this product in this container from excessiveheat and direct sun.", "ACTIVE INGRENDIENT": "Octocrylene Homosalate Octisalate Avobenzone"}