skin laundry. sun defense mineral spf 30 sunscreen broad spectrum spf 30 uva + uvb

skin laundry. sun defense mineral spf 30 sunscreen broad spectrum spf 30 uva + uvb
SPL v1
SPL
SPL Set ID 071038d9-8179-6953-e063-6394a90a8a84
Route
topical
Published
Effective Date 2023-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (182 mg)
Inactive Ingredients
arachidyl glucoside citric acid monohydrate alkekengi officinarum calyx phytate sodium calcium gluconate beta carotene polyglycerin-3 sodium benzoate tocopherol xanthan gum levomenol docosanol sodium citrate, unspecified form sodium dilauramidoglutamide lysine water medium-chain triglycerides c13-15 alkane pentylene glycol c15-19 alkane propanediol bis-diglyceryl polyacyladipate-2 gluconolactone ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) cetostearyl alcohol inositol isostearic acid coco glucoside arachidyl alcohol betasizofiran

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-14

Purpose

Sunscreen

Description

Zinc Oxide 18.2%


Medication Information

Warnings

For external use only

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.

Purpose

Sunscreen

Directions

● Apply generously 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 ging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses ● Children under 6 months: Ask a  doctor

Other Information

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

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Pentylene Glycol, C15-19 Alkane, Propanediol, Bis-Diglyceryl Polyacyladipate-2, Gluconolactone, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Cetearyl Alcohol, Inositol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Coco-Glucoside, Arachidyl Alcohol, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Sodium Benzoate, Tocopherol, Xanthan Gum, Bisabolol, Behenyl Alcohol, Sodium Citrate, Sodium Dilauramidoglutamide Lysine, Sclerotium Gum, Arachidyl Glucoside, Citric Acid, Physalis Alkekengi Calyx Extract, Sodium Phytate, Calcium Gluconate, Beta-Carotene

Description

Zinc Oxide 18.2%

Do Not Use

on damaged or broken skin

Active Ingredient

Zinc Oxide 18.2%

Package Labeling:

Question Or Comments?

Product Questions, email [email protected] You may report side effects to FDA at 1-800-FDA-1088

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


Structured Label Content

Warnings

For external use only

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.

Purpose

Sunscreen

Directions

● Apply generously 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 ging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses ● Children under 6 months: Ask a  doctor

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Pentylene Glycol, C15-19 Alkane, Propanediol, Bis-Diglyceryl Polyacyladipate-2, Gluconolactone, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Cetearyl Alcohol, Inositol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Coco-Glucoside, Arachidyl Alcohol, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Sodium Benzoate, Tocopherol, Xanthan Gum, Bisabolol, Behenyl Alcohol, Sodium Citrate, Sodium Dilauramidoglutamide Lysine, Sclerotium Gum, Arachidyl Glucoside, Citric Acid, Physalis Alkekengi Calyx Extract, Sodium Phytate, Calcium Gluconate, Beta-Carotene

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Zinc Oxide 18.2%

Package Labeling:

Question Or Comments? (Question or comments?)

Product Questions, email [email protected] You may report side effects to FDA at 1-800-FDA-1088

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.

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

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


Advanced Ingredient Data


Raw Label Data

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