Illuminating Spf 50 Plus Drops Broad Spectrum Sunscreen

Illuminating Spf 50 Plus Drops Broad Spectrum Sunscreen
SPL v2
SPL
SPL Set ID 13f40485-b98e-e804-e063-6394a90af2af
Route
TOPICAL
Published
Effective Date 2024-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24.5 g)
Inactive Ingredients
Medium-chain Triglycerides Ethylhexylglycerin Phenoxyethanol Ectoine Polyhydroxystearic Acid (2300 Mw) Tocopherol Ferric Oxide Yellow Isostearic Acid Ethyl Macadamiate Ferrosoferric Oxide Ferric Oxide Red Sodium Chloride Quaternium-90 Bentonite Stearyl Triethoxysilane C13-15 Alkane Water Propanediol Polyglyceryl-3 Pentaricinoleate Hydroxyectoin Malic Acid Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Orange Oil, Cold Pressed Lecithin, Soybean Trisodium Ethylenediamine Disuccinate Triethyl Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-22

Description

Active Ingredient Purpose Zinc Oxide........ ....Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product keep out of eyes, rinse with water to remove.

Indications and Usage

Stop use and ask a doctor is rash occurs

Dosage and Administration

Directions

  • Shake well before use
  • Apply liberally 15 minutes before sun exposure
  • Reapply
  • After 80 minutes of swimming or sweating
  • immediately after towel drying
  • Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
  • limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months of age: ask doctor
Description

Active Ingredient Purpose Zinc Oxide........ ....Sunscreen

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

Inactive Ingredients

C13-15 Alkane, Aqua/water/Eau, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polyricinoleate, Ectoin, Hydroxyectoin, Isostearic acid, Lecithin, Trisodium Ethylenediamine Disuccinate, Quaternium-90 Bentonite, Fragrance/Parfum, Citrus Aurantium Dulcis (Orange) Peel Oil, Triethyl Citrate, Tocopherol, Malic Acid, Stearyl Triethoxysilane, Sodium Chloride, Ethylhexylglycerin, Phenoxyethanol, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)

Section 51945-4

Kate Somerville

Mineral SPF 50+

Hydrakate

Illuminating SPF 50+ Drops

Broad Spectrum Sunscreen

Water Resistant (80 Minutes)

50 mL 1.7 Fl. Oz

Section 55105-1

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
Section 55106-9

Active Ingredient Purpose

Zinc Oxide........ ....Sunscreen

Section 60561-8

Other Information

Protect the product from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor is rash occurs

Dosage and Administration (34068-7)

Directions

  • Shake well before use
  • Apply liberally 15 minutes before sun exposure
  • Reapply
  • After 80 minutes of swimming or sweating
  • immediately after towel drying
  • Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
  • limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months of age: ask doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product keep out of eyes, rinse with water to remove.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

Inactive Ingredients

C13-15 Alkane, Aqua/water/Eau, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polyricinoleate, Ectoin, Hydroxyectoin, Isostearic acid, Lecithin, Trisodium Ethylenediamine Disuccinate, Quaternium-90 Bentonite, Fragrance/Parfum, Citrus Aurantium Dulcis (Orange) Peel Oil, Triethyl Citrate, Tocopherol, Malic Acid, Stearyl Triethoxysilane, Sodium Chloride, Ethylhexylglycerin, Phenoxyethanol, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)

Section 51945-4 (51945-4)

Kate Somerville

Mineral SPF 50+

Hydrakate

Illuminating SPF 50+ Drops

Broad Spectrum Sunscreen

Water Resistant (80 Minutes)

50 mL 1.7 Fl. Oz

Section 55105-1 (55105-1)

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
Section 55106-9 (55106-9)

Active Ingredient Purpose

Zinc Oxide........ ....Sunscreen

Section 60561-8 (60561-8)

Other Information

Protect the product from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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