COMPLETE BEAUTY- octinoxate lotion

Complete Beauty by

Drug Labeling and Warnings

Complete Beauty by is a Otc medication manufactured, distributed, or labeled by Vi-Jon. 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 directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For exteral 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 resistat 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10a.m. to 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• children undeer 6 months of age: ask a doctor

Other information

• protect the product from excessive heat and direct sun

Inactive ingredients

water, glycerin, isohexadecane, polysorbate 80, sodium acrylate/acryloyldimethyl taurate copolymer, laureth-7, cyclopentasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, gossypium herbaceum (cotton) seed oil, behenyl alcohol, tocopheryl acetate, cetyl alcohol, DMDM hydantoin, iodopropynyl butylcarbamate, steareth-2, disodium EDTA, aloe barbadensis leaf extract, oleth-3 phosphate

principal display panel

Complete Beauty Lotion SPF 15

6 fl oz (177 mL)

INGREDIENTS AND APPEARANCE

COMPLETE BEAUTY 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60. mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30. mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
LAURETH-7 (UNII: Z95S6G8201)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)
steareth-21 (UNII: 53J3F32P58)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
DOCOSANOL (UNII: 9G1OE216XY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
STEARETH-2 (UNII: V56DFE46J5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0503-30	1 in 1 CARTON	02/28/2006
1		177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 0869-0503-26	118 in 1 CARTON	02/28/2006
2		118 mL in 1 BOTTLE, PUMP; 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	02/28/2006

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0869-0503)