ndc-79903-316-17, advanced firming & anti wrinkle day cream

ndc-79903-316-17, advanced firming & anti wrinkle day cream
SPL v3
SPL
SPL Set ID 2617e5bc-27a2-f187-e063-6394a90a6980
Route
topical
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (70 mg) homosalate (50 mg) avobenzone (30 mg) octisalate
Inactive Ingredients
octyldodecanol ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer (52000 mpa.s) isopropyl isostearate dimethicone tetrasodium glutamate diacetate propanediol phenoxyethanol glycerin fragrance clean orc0600327 citric acid hydrolyzed soy protein (enzymatic; 2000 mw) butyloctyl salicylate cetyl alcohol peg-100 stearate polyacrylamide (10000 mw) water behenyl alcohol cetearyl glucoside cetearyl alcohol retinyl palmitate ethylhexylglycerin tocopherol panthenol pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate c13-14 isoparaffin laureth-7 centella asiatica triterpenoids

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-01
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% 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 and evenly 15 minutes before sun exposure.
  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.

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 Sopectrum SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 am-2 pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Inactive Ingredients

Water (Aqua), Glycerin, Butyloctyl Salicylate, Dimethicone, Isopropyl Isostearate, Propanediol, Cetyl Alcohol, Octyldodecanol, Phenoxyethanol, Bahenyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Cetearyl Glucoside, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Fragrance (Parfum), Retinyl Palmitate, Ethylhexylglycerin, Tocopherol, Tetrasodium Glutamate Diacetate, Polyacrylamide, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Citric Acid, C13-14 Isoparaffin, Laureth-7, Hydrolyzed Soy Protein, Panthenol, Centella Asiatica Extract.

Description

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

Pdp

Pdp 1

Do Not Use
  • On damaged or broken skin.
Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Questions/comments?

1-888-287-1915

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 and evenly 15 minutes before sun exposure.
  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.

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 Sopectrum SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 am-2 pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Inactive Ingredients

Water (Aqua), Glycerin, Butyloctyl Salicylate, Dimethicone, Isopropyl Isostearate, Propanediol, Cetyl Alcohol, Octyldodecanol, Phenoxyethanol, Bahenyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Cetearyl Glucoside, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Fragrance (Parfum), Retinyl Palmitate, Ethylhexylglycerin, Tocopherol, Tetrasodium Glutamate Diacetate, Polyacrylamide, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Citric Acid, C13-14 Isoparaffin, Laureth-7, Hydrolyzed Soy Protein, Panthenol, Centella Asiatica Extract.

Pdp (PDP)

Pdp 1 (PDP-1)

Do Not Use (Do not use)
  • On damaged or broken skin.
Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Questions/comments?

1-888-287-1915

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:54.930495 · Updated: 2026-03-14T23:08:21.075335