5283 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion 
Innovation Specialties

----------

5283 Sunscreen

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 use on damaged or broken skin.

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

Stop use and ask a doctor if 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 Copolyrner, 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

Broad Spectrum SPF30 Sunscreen Lotion

Made in China for Innovation Line
Culver City, CA 90230

Packaging

5283sunscreen

5283 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76138-222-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/31/2023
Labeler - Innovation Specialties (030837314)

Revised: 10/2023
Document Id: 72479495-f756-4bcd-8ffd-4800fe5e7c27
Set id: 3a06bb05-5965-4d7d-a299-3d48b163c604
Version: 1
Effective Time: 20231031
 
Innovation Specialties