SPF 30 SUNSCREEN- octinoxate, oxybenzone, octisalate, titanium dioxide 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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Drug Facts

Active Ingredients

Octinoxate 7.5 %

Oxybenzone 4.0 %

Octisalate 2.0 %

Titanium Dioxide 2.5%

Purpose

Sunscreen

Keep out of reach of children, If swallowed get medical help or contact  a Poison Control Center.

Directions

  • Non-Water Resistant Product.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Children under 6 months : Ask a doctor

Warnings:

This product has been shown only to prevent sunburn NOT skin cancer or early skin aging.

For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Children under 6 months : Ask a doctor

Inactive Ingredients

C12-15 Alkyl Benzoate, Ceteareth-25, Cetearyl Alcohol, Disodium EDTA, Glycerin, Glyceryl

Stearate, Myristyl Propionate, PEG-15 Cocomonium Chloride, PEG-9 Dimethicone,

Propylene Glycol Dioleate, Water, Xanthan Gum.

Product Label

SPF 30 SUNSCREEN 
octinoxate, oxybenzone, octisalate, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETEARETH-25 (UNII: 8FA93U5T67)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MYRISTYL PROPIONATE (UNII: P59053E7NJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PEG-9 DIMETHICONE (400 CST) (UNII: 9OZ27X065D)  
PROPYLENE GLYCOL DIOLEATE (UNII: 84T0LSN7U6)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76138-204-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/201305/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/05/201305/13/2022
Labeler - INNOVATION SPECIALTIES (030837314)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Dowland Daily Health Co., Ltd421264675manufacture(76138-204)

Revised: 5/2022
Document Id: 6ec5ab00-ebad-4de5-b0b3-0d8f11b14f9f
Set id: cba4d2c5-d247-45e1-8b1e-9d26fb3745f6
Version: 2
Effective Time: 20220513
 
INNOVATION SPECIALTIES