Label: DHC BRIGHTENING SUNSCREEN- titanium dioxide and zinc oxide lotion
- NDC Code(s): 63433-452-30
- Packager: DHC USA Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
-
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
-
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
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box
-
INGREDIENTS AND APPEARANCE
DHC BRIGHTENING SUNSCREEN
titanium dioxide and zinc oxide lotionProduct 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)
