Sun Bum Face 50 Premium Sunscreen Lotion Spf 50

Sun Bum Face 50 Premium Sunscreen Lotion Spf 50
SPL v3
SPL
SPL Set ID f4ac746a-a50a-8041-e053-2a95a90a8ea6
Route
TOPICAL
Published
Effective Date 2023-02-14
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
Vinylpyrrolidone/hexadecene Copolymer Dimethicone .alpha.-tocopherol Acetate Butylated Hydroxytoluene Glyceryl Monostearate Peg-100 Stearate Ethylhexyl Stearate Docosanol Caprylyl Trisiloxane Dimethyl Capramide Xanthan Gum Trideceth-6 Edetate Disodium Anhydrous Ethylhexylglycerin Methylisothiazolinone Sodium Polyacrylate (8000 Mw) Polyaminopropyl Biguanide Trimethylsiloxysilicate (m/q 0.6-0.8) Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Water Butyloctyl Salicylate Hydrated Silica

Identifiers & Packaging

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

Description

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


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
  • 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 of 15 or higher and other sun protection measures, including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.
Description

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

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, styrene/acrylates copolymer, dimethicone, polyester-8, tocopherol acetate, BHT, glyceryl stearate, PEG-100 stearate, ethylhexyl stearate, behenyl alcohol, caprylyl methicone, trimethylsiloxysilicate, dimethyl capramide, sodium polyacrylate, xanthan gum, trideceth-6, disodium EDTA, ethylhexylglycerin, polyaminopropyl biguanide, methylisothiazolinone

Section 51945-4

Sun Bum

Face 50

Premium Sunscreen Face Lotion

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

Lightweight

Breakout Free

Fragrance Free, Oxbenzone Free

Dermatologist Tested

Gluten Free

Vegan

3 FL OZ / 88 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

Avobenzone 3 %, Homosalate 10%

Octisalate 5.%, Octocrylene 10% Sunscreen

Section 60561-8

Other information

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
  • 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 of 15 or higher and other sun protection measures, including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve 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, styrene/acrylates copolymer, dimethicone, polyester-8, tocopherol acetate, BHT, glyceryl stearate, PEG-100 stearate, ethylhexyl stearate, behenyl alcohol, caprylyl methicone, trimethylsiloxysilicate, dimethyl capramide, sodium polyacrylate, xanthan gum, trideceth-6, disodium EDTA, ethylhexylglycerin, polyaminopropyl biguanide, methylisothiazolinone

Section 51945-4 (51945-4)

Sun Bum

Face 50

Premium Sunscreen Face Lotion

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

Lightweight

Breakout Free

Fragrance Free, Oxbenzone Free

Dermatologist Tested

Gluten Free

Vegan

3 FL OZ / 88 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

Avobenzone 3 %, Homosalate 10%

Octisalate 5.%, Octocrylene 10% Sunscreen

Section 60561-8 (60561-8)

Other information

protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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