sun bum signature lotion clear spf 50

sun bum signature lotion clear spf 50
SPL v3
SPL
SPL Set ID b5f52185-aed4-3fc8-e053-2995a90a3332
Route
topical
Published
Effective Date 2020-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (50 mg) octocrylene (100 mg) zinc cation
Inactive Ingredients
water alkyl (c12-15) benzoate glycerin arachidyl alcohol panthenol aloe vera leaf .alpha.-tocopherol acetate hyaluronate sodium ascorbyl palmitate yellow wax docosanol arachidyl glucoside sorbitan monooleate sorbitol xanthan gum oleic acid glyceryl caprylate edetate disodium anhydrous phenoxyethanol caprylyl glycol ethylhexylglycerin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-11-11

Purpose

Sunscreen

Description

Octisalate 5%, Octocrylene 10%. Zinc oxide 10%


Medication Information

Warnings

For externel 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
  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age:ask a doctor
  • 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:
  • limit time in the sun, especially from 10a.m. - 2.p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.
Other Information
  • protect this product from excessive heat and direct sun. Keep outer carton for complete labeling information
Inactive Ingredients

water, C12-15 alkyl benzoate, triethylpentanediol/ adipic acid copolymer, butyrospermum parkii (shee) butter, glycerin, polyster-8, arachidyl alcohol, panthenol, aloe barbadensis leaf juice, tocopheryl acetate, sodium hyaluronate, ascorbyl palmitate, beeswax, behenylalcohol, arachidyl glucoside, sorbitan oleate, sorbitol, lecithin, xanthan gum, oleic acid, glyceryl caprylate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, triethoxycaprylylate, disodium EDTA, phenoxyethanol, caprylyl glycol, ethylhexylglycerin

Description

Octisalate 5%, Octocrylene 10%. Zinc oxide 10%

Questions?

1(877)978-6286

Do Not Use

on damaged or broken skin

Drug Facts

Active Ingredients

Octisalate 5%, Octocrylene 10%. Zinc oxide 10%

Package Labeling:44ml

Package Labeling:88ml

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


Structured Label Content

Warnings

For externel 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
  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age:ask a doctor
  • 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:
  • limit time in the sun, especially from 10a.m. - 2.p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.
Other Information (Other information)
  • protect this product from excessive heat and direct sun. Keep outer carton for complete labeling information
Inactive Ingredients (Inactive ingredients)

water, C12-15 alkyl benzoate, triethylpentanediol/ adipic acid copolymer, butyrospermum parkii (shee) butter, glycerin, polyster-8, arachidyl alcohol, panthenol, aloe barbadensis leaf juice, tocopheryl acetate, sodium hyaluronate, ascorbyl palmitate, beeswax, behenylalcohol, arachidyl glucoside, sorbitan oleate, sorbitol, lecithin, xanthan gum, oleic acid, glyceryl caprylate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, triethoxycaprylylate, disodium EDTA, phenoxyethanol, caprylyl glycol, ethylhexylglycerin

Questions?

1(877)978-6286

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Active Ingredients (Active ingredients)

Octisalate 5%, Octocrylene 10%. Zinc oxide 10%

Package Labeling:44ml

Package Labeling:88ml

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


Advanced Ingredient Data


Raw Label Data

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