PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, octocrylene lotion

Premium Moisturizing Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Premium Moisturizing Sunscreen Broad Spectrum SPF 15 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

Avobenzone 2%, Homosalate 5%,

Octisalate 2%, Octocrylene 10% Purpose: 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

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, styrene/acrylates copolymer, VP/hexadecene copolymer, polyester-8, dimethicone, 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

15

Premium Moisturizing Sunscreen Lotion Broad Spectrum SPF 15

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 15 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44717-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44717-072-01	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)