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SPL v4
SPL
SPL Set ID 0c1ed603-4597-4ee5-9120-4ccf1d0a7288
Route
topical
Published
Effective Date 2023-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
meradimate (3 g) octinoxate (7.5 g) octocrylene (4 g) titanium dioxide (5 g) zinc cation (9 g)
Inactive Ingredients
phenoxyethanol propylparaben .alpha.-tocopherol vitamin a water petrolatum xanthan gum bulbine frutescens whole carboxymethylcellulose sodium, unspecified form cetostearyl alcohol glycerin glyceryl monostearate methylparaben

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-03-17

Purpose

Sunsreen

Description

 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide


Medication Information

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by sun(see Directions)
Purpose

Sunsreen

Directions
  • Apply liberally 15 minutes before sun exposure

Reapply

  • After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • 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, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limited time in the sun, espesially from 10 a.m - 2 p.m
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor

Other Information

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

Inactive Ingredients

Aloe barbadensis leaf juice, Cellulose gum, Cetearyl alcohol, Glycerin, Glycerol Stearate, Methylparaben, Phenoxyethanol, Propylparaben,

Vitamin A & E, Water, White petrolatum, Xanthan gum 

Description

 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Product Label

Active Ingredients

 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide


Structured Label Content

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by sun(see Directions)
Purpose

Sunsreen

Directions
  • Apply liberally 15 minutes before sun exposure

Reapply

  • After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • 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, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limited time in the sun, espesially from 10 a.m - 2 p.m
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf juice, Cellulose gum, Cetearyl alcohol, Glycerin, Glycerol Stearate, Methylparaben, Phenoxyethanol, Propylparaben,

Vitamin A & E, Water, White petrolatum, Xanthan gum 

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Product Label (Product label)

Active Ingredients

 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)