sun bum face mist spf 45

SPL v2

SPL

SPL Set ID b5f57f8e-7d51-3c0c-e053-2a95a90aa9ca

Route

topical

Published

Effective Date 2020-12-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg) octocrylene (70 mg)

Inactive Ingredients

alcohol isoamyl cocoate hamamelis virginiana top tocopherol

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-11-25

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%.

Medication Information

Warnings

For externel use only

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Sunscreen

Directions

shake well
apply liberally 15 minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months of age:ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10a.m. - 2.p.m.
wear long-sleeve shirts, pants, hats, and sunglasses.

Other Information

protect this product from excessive heat and direct sun.
Do not store above 104°F /40°C

Inactive Ingredients

alcohol. denat. (67%), isoamyl cocoate, fragrance, hamamelis virginiana (witch hazel) bark/leaf extract, tocopherol

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%.

Questions?

1-877-978-6286

Do Not Use

on damaged or broken skin

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%.

Package Labeling:100ml

When Using This Product

keep out of eyes. Rinse with water to remove.

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.

Structured Label Content

Warnings

For externel use only

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Sunscreen

Directions

shake well
apply liberally 15 minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months of age:ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10a.m. - 2.p.m.
wear long-sleeve shirts, pants, hats, and sunglasses.

Other Information (Other information)

protect this product from excessive heat and direct sun.
Do not store above 104°F /40°C

Inactive Ingredients (Inactive ingredients)

alcohol. denat. (67%), isoamyl cocoate, fragrance, hamamelis virginiana (witch hazel) bark/leaf extract, tocopherol

Questions?

1-877-978-6286

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%.

Package Labeling:100ml

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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

if rash occurs

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

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOAMYL COCOATE", "unii": "14OG46E98E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HAMAMELIS VIRGINIANA TOP", "unii": "UDA30A2JJY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "150", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun", "Purpose": "Sunscreen", "Warnings": "For externel use only", "Directions": "shake well apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age:ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. - 2.p.m. wear long-sleeve shirts, pants, hats, and sunglasses.", "Do not use": "on damaged or broken skin", "Questions?": "1-877-978-6286", "Other information": "protect this product from excessive heat and direct sun. Do not store above 104°F /40°C", "Active ingredients": "Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%.", "Inactive ingredients": "alcohol. denat. (67%), isoamyl cocoate, fragrance, hamamelis virginiana (witch hazel) bark/leaf extract, tocopherol", "When using this product": "keep out of eyes. Rinse with water to remove.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:05.438735 · Updated: 2026-03-14T23:00:25.149305