Diamond Luminous Uv Defense Light Tinted Fluid Sunscreen Broad Spectrum Spf 40

Diamond Luminous Uv Defense Light Tinted Fluid Sunscreen Broad Spectrum Spf 40
SPL v4
SPL
SPL Set ID bf8b71c7-257b-0eb6-e053-2a95a90a3a4c
Route
TOPICAL
Published
Effective Date 2021-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (78 mg) Zinc Cation (250 mg)
Inactive Ingredients
Water C15-19 Alkane Butyloctyl Salicylate Niacinamide Dimethicone Coco-caprylate Propanediol Peg-30 Dipolyhydroxystearate Medium-chain Triglycerides Diisopropyl Sebacate Polyglyceryl-6 Polyricinoleate Sodium Chloride Silicon Dioxide .alpha.-tocopherol Acetate Arginine Tocopherol Lysine Ascorbyl Palmitate Triethoxycaprylylsilane Stearalkonium Hectorite Polyglycerin-6 Edetate Disodium Anhydrous Propylene Carbonate Cetyl Alcohol Ethylhexylglycerin Sodium Lauroyl Glutamate Magnesium Chloride Phenoxyethanol Potassium Sorbate Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-01

Description

Titanium dioxide 7.8% Zinc oxide 25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 7.8% Zinc oxide 25%

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
Section 43683-2

Directions have changed from:

apply liberally 15 minutes before sun exposure.

reapply:

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.

To:

apply liberally 15 minutes before sun exposure.

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:

  • after 40 minutes of swimming or sweating
  • Immediately after tower drying
  • at least every 2 hours.
  • 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
  • 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.
Warnings

For external use only

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.
Do Not Use

on damaged or broken skin

Drug Facts

Questions?

1-800-762-8872 M-F 9:00 AM to 5:00 PM

Other Information

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

Active Ingredients

Titanium dioxide 7.8%

Zinc oxide 25%

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.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Package Labeling:63730 001 01

Package Labeling:63730 001 02

Package Labeling:63730 001 03

Package Labeling:63730 001 04

Keep Out of Reach of Children.

If swallowed, get medical help or contact Poison Control Center right away.


Structured Label Content

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
Section 43683-2 (43683-2)

Directions have changed from:

apply liberally 15 minutes before sun exposure.

reapply:

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.

To:

apply liberally 15 minutes before sun exposure.

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:

  • after 40 minutes of swimming or sweating
  • Immediately after tower drying
  • at least every 2 hours.
  • 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
  • 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.
Purpose

Sunscreen

Warnings

For external use only

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.
Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Questions?

1-800-762-8872 M-F 9:00 AM to 5:00 PM

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Titanium dioxide 7.8%

Zinc oxide 25%

Inactive Ingredients (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.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Package Labeling:63730 001 01 (Package Labeling:63730-001-01)

Package Labeling:63730 001 02 (Package Labeling:63730-001-02)

Package Labeling:63730 001 03 (Package Labeling:63730-001-03)

Package Labeling:63730 001 04 (Package Labeling:63730-001-04)

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact Poison Control Center right away.


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