ACTIVE SPORT- avobenzone, homosalate, octisalate. octocrylene lotion

Active Sport by

Drug Labeling and Warnings

Active Sport by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the rist 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 wth water to remove.

Stop use and ask a doctor if

• rash occurs

Keep out of reach of children

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

Directions

• apply liberally 15 minutes before sun exposure
• reapply: after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures.  Spending time in the sund increases your risk, regularly use a sunscreen with a Broad Spectrum SPF valuse of 15 or higher and other sun protection measures including: 
• limit time in the sun especially from 10 a.m -2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor

other information

• protect the product from excessive heat and direct sun

inactive ingredients

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, oleth-3, disodium EDTA

SPL UNCLASSIFIED SECTION

*This product is not being compared to Banana Boat SPORT with Powerstay Technology Sunscreen Lotion Broad Spectrum SPF 30 for any other purposes nor is this product manufactured or distributed by Edgewell Personal Care, Distributor of Banana Boat.

May stain or damage some fabrics or surfaces

Manufactured by:

Vi-Jon, Inc., St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

www.mymountainfalls.com

706.000/706AA

Principal Display Panel

mountain falls

Compare to Banana Boat 

paraben free

SPF 30 water resistant  80 minutes

non-greasy

active sport sunscreen lotion

BROAD SPECTRUM SPF 30

Made in the USA with US and foreign parts.

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

ACTIVE SPORT 
avobenzone, homosalate, octisalate. octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0706
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	101 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.5 mg  in 1 mL
oCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	oCTOCRYLENE	101 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
OLETH-3 (UNII: BQZ26235UC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0706-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2012

Labeler - Vi-Jon, Inc (790752542)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(0869-0706)