DHC BRIGHTENING SUNSCREEN- titanium dioxide and zinc oxide lotion

DHC Brightening Sunscreen by

Drug Labeling and Warnings

DHC Brightening Sunscreen by is a Otc medication manufactured, distributed, or labeled by DHC USA Incorporated, ABBE Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Titanium dioxide 8%

Zinc oxide 13%

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

• shake well before use
• apply evenly 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

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

• protect this product from excessive heat and direct sun

Questions or Comments?

800-DHC-CARE (342-2273)

DHCcare.com

SPL UNCLASSIFIED SECTION

Distributed by DHC USA Inc.
Mechanicsburg, PA 17055

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

DHC

BRIGHTENING
SUNSCREEN

SPF 30
Broad
Spectrum

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

INGREDIENTS AND APPEARANCE

DHC BRIGHTENING SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63433-452
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	80 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	130 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63433-452-30	1 in 1 BOX	03/01/2020
1		30 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 final	part352	03/01/2020

Labeler - DHC USA Incorporated (004087554)

Registrant - ABBE Laboratories, Inc. (781745286)

Establishment
Name	Address	ID/FEI	Business Operations
ABBE Laboratories, Inc.		781745286	MANUFACTURE(63433-452)