Sunscreen, Anti-mosquito Lotion

Sunscreen, Anti-mosquito Lotion
SPL v2
SPL
SPL Set ID f8f29aec-935f-e828-e053-6394a90a570a
Route
TOPICAL
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (10 g) Homosalate (3 g) Avobenzone (5 g) Octisalate
Inactive Ingredients
Peppermint Oil Citronella Oil Cetostearyl Alcohol East Indian Lemongrass Oil Water Glycerin Phenoxyethanol Yellow Wax Ceteth-25 Methylparaben Glyceryl Stearate Se Edetate Disodium Anhydrous Isopropyl Myristate Propylparaben Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-26

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by then sun.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

Warnings

For external use only

Directions
  • apply liberally 15minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediate after towel drying
  • at least every 2 hours
  • Sun Protection Measures

Spending time increases your risk of skin cancer and early skin aging. To decreases 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 10a.m.- 2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months:Ask a doctor
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Inactive Ingredients

Aqua, Glycerin, Isopropyl Myristate, Cetearyl Alcohol, Glyceryl Stearate, Ceteth-25, Beeswax, Citronella oil, Lemongrass oil, peppermint oil, Phenoxyethanol, Fragrance, Methylparaben, Propylparaben, Disodium EDTA, BHT


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by then sun.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediate after towel drying
  • at least every 2 hours
  • Sun Protection Measures

Spending time increases your risk of skin cancer and early skin aging. To decreases 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 10a.m.- 2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months:Ask a doctor
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Isopropyl Myristate, Cetearyl Alcohol, Glyceryl Stearate, Ceteth-25, Beeswax, Citronella oil, Lemongrass oil, peppermint oil, Phenoxyethanol, Fragrance, Methylparaben, Propylparaben, Disodium EDTA, BHT


Advanced Ingredient Data


Raw Label Data

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