OCTINOXATE, ZINC OXIDE lotion

Octinoxate, Zinc Oxide by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Octinoxate 6.0%

Zinc Oxide 3.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as diected 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 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 as sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, espcially 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, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, cylopentasiloxane, cyclohexasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, Gossypium Herbaceum (cotton) seed oil, behenyl alcohol, cetyl alcohol, DMDM hydantoin, iodopropynyl butylcarbamate, fragrance, tocopheryl acetate, disodium EDTA, steareth-2, oleth-3 phosphate, ascorbic acid, panthenol

disclaimer

This product is not manufactured or distributed by Procter & Gamble,

distributor of Olay All Day Moisturizer with sunscreen.

Adverse reactions

This product is not manufacture or distributed by Procter & Gamble,

distributor of Olay All Day Moisturizer with sunscreen

adverse reaction

Manufactured by: Vi-Jon, Inc

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

909.005/909AE

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, ZINC OXIDE 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0909
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	61.2 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LAURETH-7 (UNII: Z95S6G8201)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)
STEARETH-21 (UNII: 53J3F32P58)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STEARETH-2 (UNII: V56DFE46J5)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0909-26	1 in 1 BOX	03/17/2016
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0869-0909-30	1 in 1 BOX	03/17/2016
2		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/17/2016

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0869-0909)