Live Tinted. Glow-up Hyperpigmentation Essentials

Live Tinted. Glow-up Hyperpigmentation Essentials
SPL v2
SPL
SPL Set ID ef06c1eb-6ce3-4b1b-8a7d-3e29ae172844
Route
TOPICAL
Published
Effective Date 2023-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (182.3 mg)
Inactive Ingredients
Water Medium-chain Triglycerides C13-15 Alkane Propanediol C15-19 Alkane Tocopherol Octyldodecanol Inositol Silicon Dioxide Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Isostearic Acid Xanthan Gum Coco Glucoside Polyglycerin-3 Levomenol Caprylhydroxamic Acid Sodium Dilauramidoglutamide Lysine Sodium Citrate, Unspecified Form Citric Acid Monohydrate Arachidyl Glucoside Phytate Sodium Glycerin Alkekengi Officinarum Calyx Biosaccharide Gum-1 Sodium Levulinate Glyceryl Caprylate Cetostearyl Alcohol Tert-butyl Alcohol Sodium Anisate Anhydrous Dextrose Beta Carotene Docosanol Arachidyl Alcohol Ferric Oxide Yellow Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-06

Description

Zinc Oxide 18.23%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18.23%

Uses

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



Stop Use

if rash occurs and ask a doctor.

Warnings

For external use only

Directions

• Apply liberally to face and neck for everyday moisture and protection. • Can be worn alone or under makeup. • Reapply at least every two hours. • Pair with a waterresistant SPF when 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 value of 15 or higher and other sun protection methods such as: • 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.















Do Not Use

on damaged or broken skin. Keep out of eyes. Rinse with water to remove.

Active Ingredient

Zinc Oxide 18.23%

Package Labeling:

Inactive Ingredient

Water (Aqua), Caprylic Capric Triglyceride, C13-15 Alkane, Propanediol, C15-19 Alkane, Bisdiglyceryl Polyacyladipate-2, Tocopherol, Octyldodecanol, Polyhydroxystearic Acid, Inositol, Hippophae Rhamnoides Oil, Silica, Polyacrylate Cross-Polymer-6, Isostearic Acid, Lecithin, Polyglyceryl- 3 Polyricinoleate, Xanthan Gum, Cocoglucoside, Polyglycerin-3, Polyglyceryl-3 Lactate / Laurate, Bisabolol, Caprylhydroxamic Acid, Sodium Dilauramidoglutamide Lysine, Sodium Citrate, Citric Acid, Arachidyl Glucoside, Sodium Phytate, Glycerin, Physalis Alkekengi Calyx Extract, Biosaccharide Gum-1, Sodium Levulinate, Glyceryl Caprylate, Cetearyl Alcohol, T-butyl Alcohol, Sodium Anisate, Glucose, Betacarotene, Behenyl Alcohol, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491)

Keep Out of Reach of Children

if swallowed, get medical help orcontact a Poison Control Center right away.


Structured Label Content

Uses

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



Purpose

Sunscreen

Stop Use (Stop use)

if rash occurs and ask a doctor.

Warnings

For external use only

Directions

• Apply liberally to face and neck for everyday moisture and protection. • Can be worn alone or under makeup. • Reapply at least every two hours. • Pair with a waterresistant SPF when 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 value of 15 or higher and other sun protection methods such as: • 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.















Do Not Use (Do not use)

on damaged or broken skin. Keep out of eyes. Rinse with water to remove.

Active Ingredient

Zinc Oxide 18.23%

Package Labeling:

Inactive Ingredient

Water (Aqua), Caprylic Capric Triglyceride, C13-15 Alkane, Propanediol, C15-19 Alkane, Bisdiglyceryl Polyacyladipate-2, Tocopherol, Octyldodecanol, Polyhydroxystearic Acid, Inositol, Hippophae Rhamnoides Oil, Silica, Polyacrylate Cross-Polymer-6, Isostearic Acid, Lecithin, Polyglyceryl- 3 Polyricinoleate, Xanthan Gum, Cocoglucoside, Polyglycerin-3, Polyglyceryl-3 Lactate / Laurate, Bisabolol, Caprylhydroxamic Acid, Sodium Dilauramidoglutamide Lysine, Sodium Citrate, Citric Acid, Arachidyl Glucoside, Sodium Phytate, Glycerin, Physalis Alkekengi Calyx Extract, Biosaccharide Gum-1, Sodium Levulinate, Glyceryl Caprylate, Cetearyl Alcohol, T-butyl Alcohol, Sodium Anisate, Glucose, Betacarotene, Behenyl Alcohol, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491)

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

if swallowed, get medical help orcontact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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