87353-001

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (2 g) Avobenzone (1 g) Octisalate

Inactive Ingredients

Microcrystalline Wax Bht Ethylhexyl Palmitate Ceresin Beeswax Polyisobutylene (1000 Mw) Phenoxyethanol Butyrospermum Parkii (shea) Butter

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-01-22

Medication Information

Purpose

Sunscreen

Description

Octinoxate 2%,Avobenzone 1%,Octisalate 1%

Uses

- helps protect against sunbumn and chapped lips

- higher SPF gives more sunburn protection

Warnings

1. Skin Cancer/Skin Aging Alert: Spending time in the sun increasesyour risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skinaging.

2. For external use only

87353 001

Directions

apply liberally 15 minutes before sun exposure

reapply: at least every 2 hours

children under 2 years of age: ask a doctor

Do Not Use

on damaged or broken skin

Active Ingredient

Octinoxate 2%,Avobenzone 1%,Octisalate 1%

Inactive Ingredients

Ozokerite, Polyisobutene,Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea)Butter,Microcrystalline Wax, Phenoxyethanol, Fragrance(Parfum),BHT

When Using This Product

keep out of eyes. Rinse with water toremove.

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children.

lf swallowed, get medical help orcontact a Poison Control Center right away.

Structured Label Content

Uses

- helps protect against sunbumn and chapped lips

- higher SPF gives more sunburn protection

Purpose

Sunscreen

Warnings

1. Skin Cancer/Skin Aging Alert: Spending time in the sun increasesyour risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skinaging.

2. For external use only

87353 001 (87353-001)

Directions

apply liberally 15 minutes before sun exposure

reapply: at least every 2 hours

children under 2 years of age: ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Octinoxate 2%,Avobenzone 1%,Octisalate 1%

Inactive Ingredients (Inactive ingredients)

Ozokerite, Polyisobutene,Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea)Butter,Microcrystalline Wax, Phenoxyethanol, Fragrance(Parfum),BHT

When Using This Product (When using this product)

keep out of eyes. Rinse with water toremove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

lf swallowed, get medical help orcontact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BHT", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL PALMITATE", "unii": "2865993309", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYISOBUTYLENE (1000 MW)", "unii": "5XB3A63Y52", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BUTYROSPERMUM PARKII (SHEA) BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "- helps protect against sunbumn and chapped lips - higher SPF gives more sunburn protection", "Purpose": "Sunscreen", "Warnings": "1. Skin Cancer/Skin Aging Alert: Spending time in the sun increasesyour risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skinaging. 2. For external use only", "Directions": "apply liberally 15 minutes before sun exposure reapply: at least every 2 hours children under 2 years of age: ask a doctor", "Do not use": "on damaged or broken skin", "Active ingredient": "Octinoxate 2%,Avobenzone 1%,Octisalate 1%", "Inactive ingredients": "Ozokerite, Polyisobutene,Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea)Butter,Microcrystalline Wax, Phenoxyethanol, Fragrance(Parfum),BHT", "When using this product": "keep out of eyes. Rinse with water toremove.", "Stop use and ask a doctor if": "rash occurs", "Keep out of reach of children.": "lf swallowed, get medical help orcontact a Poison Control Center right away."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information