PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Premium Moisturizing Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Premium Moisturizing Sunscreen Broad Spectrum 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: Sunscreen

Avobenzone 3%, Homosalate 10%,
Octisalate 5%, Octocrylene 10%

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 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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44717-069
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
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DIMETHICONE 100 (UNII: RO266O364U)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DOCOSANOL (UNII: 9G1OE216XY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44717-069-01	177 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)