OTC Medication Information: GoodSense SPF 30 Sunscreen

GOODSENSE SPF 30 SUNSCREEN- octisalate, avobenzone, octocrylene and homosalate lotion
Geiss, Destin, & Dunn, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes 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.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Oleth-3, Polyamide-8, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.

Label

Label
(click image for full-size original)

GOODSENSE SPF 30 SUNSCREEN
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-221
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
EDETATE DISODIUM
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
MEDIUM-CHAIN TRIGLYCERIDES
DIETHYLHEXYL SYRINGYLIDENEMALONATE
TOCOPHEROL
BENZYL ALCOHOL
ETHYLHEXYL PALMITATE
OLETH-3
POLYAMIDE-8 (4500 MW)
VITAMIN A PALMITATE
SODIUM ASCORBYL PHOSPHATE
SORBITOL
CHLORPHENESIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50804-221-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/21/2019
Labeler — Geiss, Destin, & Dunn, Inc. (076059836)

Revised: 01/2023 Geiss, Destin, & Dunn, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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