SUN BUM FACE 50 PREMIUM SUNSCREEN SPF 50- avobenzone, homosalte, octisalate, octocrylene lotion

Sun Bum Face 50 Premium Sunscreen SPF 50 by

Drug Labeling and Warnings

Sun Bum Face 50 Premium Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Wasatch Product Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Avobenzone 3 %, Homosalate 10%

Octisalate 5.%, Octocrylene 10% Sunscreen

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & 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.

OTHER SAFETY INFORMATION

Other information

protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SUN BUM FACE 50 PREMIUM SUNSCREEN SPF 50 
avobenzone, homosalte, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44717-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DOCOSANOL (UNII: 9G1OE216XY)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44717-080-01	88 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/01/2023

Labeler - Wasatch Product Development, LLC (962452533)