5281 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion

5281 SUNSCREEN by

Drug Labeling and Warnings

5281 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Innovation Specialties. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose:

Sunscreen

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.

Warnings

For external use only

Do not useon damaged or broken skin.

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

Stop use and ask a doctorif rash occurs.

Keep out of Reach of Children.If product swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes exposure. reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours.

Sun Protection Measure.
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 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 children under 6 months: Ask a doctor.

Inactive ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

Call:1-855-755-5346

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF30

Product # 5281
Made in China for Innovation Line
Culver City, CA 90230

Packaging

INGREDIENTS AND APPEARANCE

5281 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76138-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LEVOMENOL (UNII: 24WE03BX2T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76138-219-05	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/10/2022

Labeler - Innovation Specialties (030837314)