DHC BRIGHTENING SUNSCREEN- titanium dioxide and zinc oxide lotion 
DHC USA Incorporated

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DHC Brightening Sunscreen

Drug Facts

Active Ingredients

Titanium dioxide 8%

Zinc oxide 13%

Purpose

Sunscreen

Uses

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

Inactive Ingredients

cyclopentasiloxane, water, talc, dimethicone, PEG-10 dimethicone, triethylhexanoin, glycerin, alumina, nylon-12, olea europaea (olive) fruit oil, butylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, methicone, phenoxyethanol, hydrogen dimethicone, alpha-arbutin, pentylene glycol, aloe barbandensis leaf juice, pentasodium pentetate, tocopherol, tricalcium phosphate, ascorbyl tetraisopalmitate, olea europaea (olive) leaf extract, citric acid, magnolia obovate extract, silica, silver

Other Information

Questions or Comments?

800-DHC-CARE (342-2273)

DHCcare.com

Distributed by DHC USA Inc.
Mechanicsburg, PA 17050

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

DHC

BRIGHTENING
SUNSCREEN

SPF 30
Broad
Spectrum

1 fl. oz. U.S. (30 ml)

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box
DHC BRIGHTENING SUNSCREEN 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63433-452
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide80 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide130 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Water (UNII: 059QF0KO0R)  
Talc (UNII: 7SEV7J4R1U)  
Dimethicone (UNII: 92RU3N3Y1O)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
Triethylhexanoin (UNII: 7K3W1BIU6K)  
Glycerin (UNII: PDC6A3C0OX)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Nylon-12 (UNII: 446U8J075B)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
Butylene glycol (UNII: 3XUS85K0RA)  
PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: TYP81E471F)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ALPHA-ARBUTIN (UNII: 72VUP07IT5)  
Pentylene Glycol (UNII: 50C1307PZG)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Pentasodium Pentetate (UNII: 961TOZ5L7T)  
Tocopherol (UNII: R0ZB2556P8)  
Tricalcium Phosphate (UNII: K4C08XP666)  
Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Silver (UNII: 3M4G523W1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63433-452-301 in 1 BOX03/01/2020
130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2020
Labeler - DHC USA Incorporated (004087554)
Registrant - ABBE Laboratories, Inc. (781745286)
Establishment
NameAddressID/FEIBusiness Operations
ABBE Laboratories, Inc.781745286MANUFACTURE(63433-452)

Revised: 2/2022
Document Id: 688c7024-ed92-4db3-8147-06f1fabd38da
Set id: 1233cd64-f325-4a75-85c0-400b015564ca
Version: 2
Effective Time: 20220228
 
DHC USA Incorporated