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NDC 75981-0909-30 Beauty Hydrating 61.2; 30.6 mg/mL; mg/mL Details

Beauty Hydrating 61.2; 30.6 mg/mL; mg/mL

Beauty Hydrating is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Geiss, Destin + Dunn, Inc. The primary component is OCTINOXATE; ZINC OXIDE.

Product Information

NDC	75981-0909
Product ID	75981-909_63dfbd79-5a38-4a50-a1f5-5dd2f0863544
Associated GPIs
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	Beauty Hydrating
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	61.2; 30.6
Active Ingredient Units	mg/mL; mg/mL
Substance Name	OCTINOXATE; ZINC OXIDE
Labeler Name	Geiss, Destin + Dunn, Inc
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 75981-0909-30 (75981090930)

Pricing Information	N/A
NDC Package Code	75981-909-30
Billing NDC	75981090930
Package	1 BOTTLE, PLASTIC in 1 PACKAGE (75981-909-30) / 177 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2006-11-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4e4e5388-0298-4f52-a51d-5b9bbfbd2308 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 a Broad Spectrum SPF value of 15 or higher 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

Inactive ingredients

water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, cyclopentasiloxane, cyclohexasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, Gossypium Herbaceum (cotton)seed oil, behenyl alcohol, cetyl alcohol, DMDM hydantoin, iodopropynyl butylcarbamate, fragrance, tocohperyl acetate, disodium EDTA, steareth-2, oleth-3 phosphate, ascorbic acid, panthenol

SPL UNCLASSIFIED SECTION

Complete

Oil of Beauty Sunscreen Moisture Lotion

100% Aminobenzoic Acid (PABA)-Free

Dermatologist Tested

Light, Non-Greasy Formula

Non-Comedogenic (Won't Clog Pores)

Broad-spectrum UVA and UVB Protection with SPF 15 to help prevent premature skin damage.

ALL DAY MOISTURE - formulated with antioxidant Vitamin E plus C and nourishing beauty moisture that absorbs quickly into sking and lasts all day to help your skin stay soft, smoothe and beautiful.

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

DISTRIBUTED BY:

Geiss, Destin, & Dunn, Inc.

Peachtree City, GA 30269

www. valuelabels.com

1-866-696-0957

principal display panel

GoodSense

Complete Oil of Beauty Sunscreen Moisture Lotion

SPF 15

Broad-spectrum UVA and UVB protection with SPF 15 to help precent premature

skin damage

Compare to active ingredients of Olay Complete

100% SATISFACTION GUARANTEED

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

BEAUTY HYDRATING

octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75981-909
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75981-909-30	1 in 1 PACKAGE	11/08/2006
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 not final	part352	11/08/2006

Labeler - Geiss, Destin + Dunn, Inc (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(75981-909)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(75981-909)

Revised: 9/2022

Document Id: 63dfbd79-5a38-4a50-a1f5-5dd2f0863544

Set id: 4e4e5388-0298-4f52-a51d-5b9bbfbd2308

Version: 12

Effective Time: 20220929