Sun Bum Spf 50 Premium Moisturizing Sunscreen Lotion

Sun Bum Spf 50 Premium Moisturizing Sunscreen Lotion
SPL v3
SPL
SPL Set ID f434089c-126f-441c-e053-2995a90ab0c7
Route
TOPICAL
Published
Effective Date 2023-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene
Inactive Ingredients
Glyceryl Monostearate Caprylyl Trisiloxane Water Butyloctyl Salicylate Hydrated Silica Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Ethylhexyl Stearate Trideceth-6 Vinylpyrrolidone/hexadecene Copolymer Dimethicone 100 Sodium Polyacrylate (2500000 Mw) Docosanol Trimethylsiloxysilicate (m/q 0.6-0.8) Xanthan Gum .alpha.-tocopherol Acetate Dimethyl Capramide Peg-100 Stearate Ethylhexylglycerin Polyaminopropyl Biguanide Methylisothiazolinone Butylated Hydroxytoluene Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01
Description

Active ingredients Purpose: Sunscreen Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on damaged or broken skin

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

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

  • shake well before use
  • 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 your time in the sun, especially from 10a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Description

Active ingredients Purpose: Sunscreen Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredients

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, dimethicone, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone

Section 51945-4

Sun Bum

50

Premium Moisturizing Sunscreen Lotion

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

Gluten Free and Vegan

Antioxidant Enriched (Vitamin E)

Dermatologist Tested

6 FL OZ / 177 mL

Section 55105-1

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
Section 55106-9

Active ingredients Purpose: Sunscreen

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Section 60561-8

Protect this product from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

  • shake well before use
  • 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 your time in the sun, especially from 10a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use on damaged or broken skin

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredients

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, dimethicone, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone

Section 51945-4 (51945-4)

Sun Bum

50

Premium Moisturizing Sunscreen Lotion

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

Gluten Free and Vegan

Antioxidant Enriched (Vitamin E)

Dermatologist Tested

6 FL OZ / 177 mL

Section 55105-1 (55105-1)

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
Section 55106-9 (55106-9)

Active ingredients Purpose: Sunscreen

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.923790 · Updated: 2026-03-14T23:13:00.870746