SPORT SUNBLOCK- octinoxate and titanium dioxide lotion 
Kareway Product, Inc.

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

Octyl Methoxycinnamate 7%

Titanium Dioxide 2.8%

Purpose

Sunscreen

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

Directions

Other information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Glycerin, Stearic acid,

Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate,

Phenoxyethanol, Triethanolamine, Dimethicone, Acrylates/

C10-30 alkyl acrylate crosspolymer, Chlorphenesin,

Lavandula Angustifolia (Lavender) Extract, Salvia Sclarea

(Clary) Extract, Hyacinthus Orientalis Extract, Chamomilla

Recutita (Matricaria) Flower/Leaf Extract, Borago officinalis

Extract, Centaurea cyanus flower Extract, Butylene Glycol,

1,2- Hexanediol, Ethylhexylglycerin, Disodium EDTA, Fragrance

Package label

Sport Sunscreen

tube

SPORT SUNBLOCK 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0083-5100 mL in 1 TUBE; Type 0: Not a Combination Product10/27/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/27/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 10/2019
Document Id: 941ef71f-3432-25ed-e053-2995a90a0f05
Set id: 125ecc02-db75-4eb2-a8bf-f555658d3572
Version: 5
Effective Time: 20191004
 
Kareway Product, Inc.