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NDC 11822-0091-06 Complete Beauty 60; 30 mg/mL; mg/mL Details

Complete Beauty 60; 30 mg/mL; mg/mL

Complete Beauty is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid. The primary component is OCTINOXATE; ZINC OXIDE.

Product Information

NDC	11822-0091
Product ID	11822-0091_91fe03fe-646b-4fb2-949d-aec68d85129f
Associated GPIs	99850000000100
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Complete Beauty
Proprietary Name Suffix	n/a
Non-Proprietary Name	octinoxate, zinc oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	60; 30
Active Ingredient Units	mg/mL; mg/mL
Substance Name	OCTINOXATE; ZINC OXIDE
Labeler Name	Rite Aid
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 11822-0091-06 (11822009106)

Pricing Information	N/A
NDC Package Code	11822-0091-6
Billing NDC	11822009106
Package	1 BOTTLE, PLASTIC in 1 CARTON (11822-0091-6) / 177 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2010-03-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4c25a5e0-501f-4bd6-a031-a6c48f14ed31 Details

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 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 a sunscreen with Broad Spectrum SPF value 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, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, Gossypium herbaceum (cotton) seed oil, behenyl alcohol, tocopheryl acetate, cetyl alcohol, steareth-2, disodium EDTA, Aloe barbadensis leaf extract, oleth-3 phosphate, benzyl alcohol

SPL UNCLASSIFIED SECTION

complete beauty lotion

BROAD SPECTRUM SPF 15 SUNSCREEN MOISTURIZER SPF 15

daylogic complete beauty lotion

BROAD SPECTRUM SPF 15 SUNSCREEN MOISTURIZER SPF 15

*This product is not manufactured or distributed by Procter & Gamble, distributor of Olay Complete All Day Moisturer Lotion

MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS

look great feel great

100% GUARANTEE or your money back

Distributed by Rite Aid

30 Hunter Lane

Camp Hill, PA 17011

principal display planel

daylogic

complete beauty lotion

BROAD SPECTRUM SPF 15 SUNSCREEN MOISTURIZER

SPF 15

DERMATOLOGIST TESTED

Sensitive Skin

UVA/UVB Protection

Vitamin E & Aloe

Compare to Olay Complete All Day Moisture Lotion*

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

COMPLETE BEAUTY

octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0091
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHLORPHENESIN (UNII: I670DAL4SZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-0091-6	1 in 1 CARTON	03/13/2010
1		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/13/2010

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(11822-0091)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(11822-0091)

Revised: 6/2022

Document Id: 91fe03fe-646b-4fb2-949d-aec68d85129f

Set id: 4c25a5e0-501f-4bd6-a031-a6c48f14ed31

Version: 15

Effective Time: 20220623