drug facts

drug facts
SPL v6
SPL
SPL Set ID 071bfb80-d980-4e62-9cd6-96149f1ba04a
Route
topical
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg) octocrylene (70 mg)
Inactive Ingredients
water nylon-12 glyceryl stearate se perlite chlorphenesin maltodextrin peg-8 laurate phenoxyethanol propylene glycol sodium stearoyl glutamate tocopherol xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-10-17

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 7%


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:
  • after 80 minutes of swimming or sweating
  • immediately fter 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 SOF calue of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially between 10 a.m. and 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

water, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, menthyl methacrylae crosspolymer, nylon-12, PEG-100, glyceryl stearate, perlite, beeswax, ammonium poolyacrylloyldiimethy taurate, behenyl alcohol, caprylic/capric triglyceride, cassia alata leaf extract, chlorphenesisn, diethylhexyl syringlyidenemalonate, disodium EDTA, maltodextrin, p-anisic acid, PEG-8 laurate, phenoxethanol, propylene glycol, sodium stearoyl glutamate, tocopherol, xanthan gum

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 7%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Questions Or Comments?

1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

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 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:
  • after 80 minutes of swimming or sweating
  • immediately fter 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 SOF calue of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially between 10 a.m. and 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)

water, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, menthyl methacrylae crosspolymer, nylon-12, PEG-100, glyceryl stearate, perlite, beeswax, ammonium poolyacrylloyldiimethy taurate, behenyl alcohol, caprylic/capric triglyceride, cassia alata leaf extract, chlorphenesisn, diethylhexyl syringlyidenemalonate, disodium EDTA, maltodextrin, p-anisic acid, PEG-8 laurate, phenoxethanol, propylene glycol, sodium stearoyl glutamate, tocopherol, xanthan gum

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Questions Or Comments? (Questions or comments?)

1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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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