BEAUTY HYDRATING- homosalate, zinc oxide lotion

Beauty Hydrating by

Drug Labeling and Warnings

Beauty Hydrating by is a Otc medication manufactured, distributed, or labeled by Topco, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 5.0%

Zinc oxide 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

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 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

Inactive ingredients

water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, cyclopentasiloxane, cyclohexasiloxane, tocopheryl acetate, Aloe barbadensis leaf extract, steareth-21, stearyl alcohol, caprylyl glycol, behenyl alcohol, phenoxyethanol, cetyl alcohol, fragrance, hydroxyacetophenone, disodium EDTA, steareth-2, oleth-3 phosphate

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROOVE VILLAGE, KL 60007

TOPCO CIJA0321  QUESTIONS? 1-888-423-0139

topcare@topco.com  www.topcarebrand.com

Visit here for more information: http://topbrnds.com/48zz82

QUALITY GUARANTEED

This product is not manufactured or distributed by Procter & Gamble, distributor of Olay Complete UC365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 15 Normal.

**Oxybenzone & Octinoxate Free

May stain or damage some fabrics or surfaces

principal display panel

TopCare

beauty

ALL-DAY

MOISTURIZER

Sunscreen Lotion For Normal Skin

Compare to OLAY

Broad spectrum SPF 12

REEF FRIENDLY

SPF 15

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

BEAUTY HYDRATING 
homosalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-513
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)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARETH-21 (UNII: 53J3F32P58)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DOCOSANOL (UNII: 9G1OE216XY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
STEARETH-2 (UNII: V56DFE46J5)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-513-30	1 in 1 PACKAGE	06/02/2020
1		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 not final	part352	06/02/2020

Labeler - Topco (006935977)

Registrant - Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(36800-513)