DIAMOND LUMINOUS UV DEFENSE LIGHT TINTED FLUID SUNSCREEN BROAD SPECTRUM SPF 40- titanium dioxide, zinc oxide lotion

Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by NATURA BISSE INTERNATIONAL SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium dioxide 7.8%

Zinc oxide 25%

Purpose

Sunscreen

Uses

• helps prevent sunburn.
• If used as directed with other sun protection measures (see  ) decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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 Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure.

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: Sun Protection Measures.

• limit time in the sun, especially from 10 a.m.–2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses.
• children under 6 months: Ask a doctor
• reapply at least every 2 hours.
• use a water resistant sunscreen if swimming or sweating.

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Water, C15-19 Alkane, Butyloctyl Salicylate, Niacinamide, Dimethicone, Coco-Caprylate Propanediol, PEG-30 Dipolyhydroxystearate, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-6 Polyhydroxystearate, Diisopropyl Sebacate, Polyhydroxystearic Acid, Sodium Chloride, Silica, Tocopheryl Acetate, Arginine, Artemia Extract, Tocopherol, Lysine, Ascorbyl Palmitate,Triethoxycaprylylsilane, Stearalkonium Hectorite, Polyglycerin-6, Disodium EDTA, Propylene Carbonate, Cetyl Alcohol, Ethylhexylglycerin, Sodium Lauroyl Glutamate, Magnesium Chloride, Phenoxyethanol, Potassium Sorbate, Fragrance, Iron Oxides.

Questions?

1-800-762-8872 M-F 9:00 AM to 5:00 PM

Package Labeling:63730-001-01

Package Labeling:63730-001-02

Package Labeling:63730-001-03

Package Labeling:63730-001-04

INGREDIENTS AND APPEARANCE

DIAMOND LUMINOUS UV DEFENSE LIGHT TINTED FLUID SUNSCREEN BROAD SPECTRUM SPF 40 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63730-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C15-19 ALKANE (UNII: CI87N1IM01)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCO-CAPRYLATE (UNII: 4828G836N6)
PROPANEDIOL (UNII: 5965N8W85T)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGININE (UNII: 94ZLA3W45F)
TOCOPHEROL (UNII: R0ZB2556P8)
LYSINE (UNII: K3Z4F929H6)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYGLYCERIN-6 (UNII: M51422LRAM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63730-001-01	4 mL in 1 PACKET; Type 0: Not a Combination Product	06/01/2021
2	NDC: 63730-001-02	1 in 1 BOX	06/01/2021
2		10 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 63730-001-03	1 in 1 BOX	06/01/2021
3		30 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 63730-001-04	1 in 1 BOX	06/01/2021
4		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2021

Labeler - NATURA BISSE INTERNATIONAL SA (464431576)