SPL v5
SPL
SPL Set ID a93cd61a-ae83-4c45-8fca-f904b5cf706d
Route
TOPICAL
Published
Effective Date 2022-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
Water Medium-chain Triglycerides Glycerin Squalane Cetostearyl Alcohol Methyl Dihydroabietate Sorbitan Olivate Cetyl Palmitate Coco Glucoside Ethyl Ferulate Isostearic Acid Lecithin, Soybean Polyglyceryl-3 Ricinoleate Polyhydroxystearic Acid (2300 Mw) Caprylyl/capryl Oligoglucoside Acacia Senegal Whole Xanthan Gum Sodium Gluconate Bisabolol Oxide A Hydroxyacetophenone Hexanediol Caprylyl Glycol Physalis Angulata

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-06-01

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

Uses

Helps prevent sunburn

if used as directed with other sun protection measures(see ​directions)​, decreases the risk of skkin cancer and early signs of aging caused by the sun.

Section 51945-4

Warnings

  For external use only

Directions
  •  Apply generously 15 minutes before sun exposure
  • reapply at least  every 2 hours
  • ​Sun Protection Measures   ​Spending time in the sun increases your risk of skin cancer and early skin aging.   To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 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 shiirts, pants, hats and sunglasses
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age:ask a doctor.
Do Not Use

on damaged of broken skin

Stop Use and Ask

a doctor if rash occurs

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Cetyl Palmitate, Coco-Glucoside, Ethyl Ferulate, Bisabolol, Hydroxyacetophenone, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, 1,2-Hexandiol, Caprylyl Glycol, Physalis Angulata Extract, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate.

When Using This Product

keep out of eyes.  Rinse with water to remove

Keep Out of Reach of Children

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


Structured Label Content

Uses

Helps prevent sunburn

if used as directed with other sun protection measures(see ​directions)​, decreases the risk of skkin cancer and early signs of aging caused by the sun.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

  For external use only

Directions
  •  Apply generously 15 minutes before sun exposure
  • reapply at least  every 2 hours
  • ​Sun Protection Measures   ​Spending time in the sun increases your risk of skin cancer and early skin aging.   To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 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 shiirts, pants, hats and sunglasses
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age:ask a doctor.
Do Not Use (Do not use)

on damaged of broken skin

Stop Use and Ask (Stop use and ask)

a doctor if rash occurs

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Cetyl Palmitate, Coco-Glucoside, Ethyl Ferulate, Bisabolol, Hydroxyacetophenone, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, 1,2-Hexandiol, Caprylyl Glycol, Physalis Angulata Extract, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate.

When Using This Product (When using this product)

keep out of eyes.  Rinse with water to remove

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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