OCTINOXATE, OCTISALATE, AVOBENZONE lotion

Octinoxate, Octisalate, Avobenzone by

Drug Labeling and Warnings

Octinoxate, Octisalate, Avobenzone by is a Otc medication manufactured, distributed, or labeled by Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Octisalate 5.0%

Avobenzone 3.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

Stop use and ask a doctor if

rash occurs

When using this product

keep out of eyes.  Rinse with water to remove.

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 at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection measures.  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 value of 15 or highter and other sun protection measures including:
• limit the 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
• may stain some fabrics

Inactive ingredients

water, diisopropyl adipate, cyclomethicone, glycerin, undecylcrylene dimethicone, glyceryl stearate, PEG-100 stearate, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, tocopyeryl acetate, carbomer, disodium EDTA, trietanoolamine, potassium sorbate

claims

This product is not manufactured or distributed by Galdema Laboatories, L.P.,  distributor of Cetaphil Daily Facial Moisturizer SPF 15

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

principal display panel

mountain

falls

Compare

to Olay

won't

clog Pores

UVA/UVB

protection

vitamin

E & C

enriched

SPF

15

moisturizing

beuty lotion

broad spectrum

SPF 15

sunscreen

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

OCTINOXATE, OCTISALATE, AVOBENZONE 
octinoxate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0995
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	76.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.0 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYL METHACRYLATE (UNII: 196OC77688)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TOCOPHEROL (UNII: R0ZB2556P8)
CARBOMER 940 (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEARETH-2 (UNII: V56DFE46J5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0995-26	141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/25/2016

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0869-0995)