OTC Medication Information: Sunscreen

SUNSCREEN- avobenzone, homosalate, octisalate and oxybenzone spray
OLD EAST MAIN CO.

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 15%

Octisalate 5%

Oxybenzone 6%

Purpose

Sunscreen

Use

  • 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

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking.

Do not use

on damaged or broken skin

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.

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 in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. — 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 from excessive heat and direct sun
  • avoid long term storage above 40°C (104°F)

Inactive ingredients

alcohol denat., acrylates/octylacrylamide copolymer, glycerin, Aloe barbadensis leaf extract, fragrance, Cocos nucifera (coconut) oil, mineral oil

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Kids Sunscreen Continuous Spray Broad Spectrum SPF 50.

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DISTRIBUTED BY DOLGENCORP, LLC

100 ISSION RIDGE

GOODLETTSVILLE, TN 37072

principal display panel

DG body

Compare to the active ingredients in Coppertone

Sunscreen Spray for kids

Broad Spectrum SPF 50

  • Water Resistant (80 minutes)
  • UVA/UVB Sunscreen

SPF 50

NET WT 6 OZ (170 g)

image description
(click image for full-size original)
SUNSCREEN
avobenzone, homosalate, octisalate, oxybenzone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-727
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (AVOBENZONE) Avobenzone 26.49 mg in 1 g
Homosalate (HOMOSALATE) Homosalate 132.45 mg in 1 g
Octisalate (OCTISALATE) Octisalate 44.15 mg in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 52.98 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER
GLYCERIN
ALOE VERA LEAF
COCONUT OIL
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-727-30 170 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/21/2017
Labeler — OLD EAST MAIN CO. (068331990)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (55910-727)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (55910-727)

Revised: 10/2023 OLD EAST MAIN CO.

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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