5281 SUNSCREEN- octocrylene, titanium dioxide, octisalate lotion 
Innovation Specialties

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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5281 sunscreen

Drug Facts

Active Ingredient

Octocrylene 9%

Titanium dioxide 7%

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 products is swallowed, get medical help or contact a Poison Control Center right away.

Directions

•apply liberally 15 minutes before sun 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, C12-15 Alkyl Benzoate, Isopropyl Myristate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, CETETH-25, Glyceryl Stearate, Glycerin, Dmdm Hydantoin, Methyl Paraben, Propylparaben, Fragrance

Other information

•protect this product from excessive heat and direct sun

NDC (76138-213-05)

DIN 02448890
Made in China for Innovation line.
Los Angeles CA 90066
Questions or Comments?
Call:1-855-755-5346

Broad Spectrum SPF 30 Sunscreen Lotion

Packaging

image description

5281 SUNSCREEN 
octocrylene, titanium dioxide, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-25 (UNII: 5KLY4IOG20)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76138-213-0515 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201805/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/201805/13/2022
Labeler - Innovation Specialties (030837314)

Revised: 5/2022
 
Innovation Specialties