Sunscreen Lotion
FDA Label NDC 75712-950

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Sunscreen (NDC 75712-950). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Purpose

Sunscreen

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

Warnings

For external use only

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 liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 in this container from excessive heat and direct sun

Inactive Ingredients

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, benzyl alcohol, disodium EDTA, sodium ascorbyl phosphate, fragrance

Disclaimer

May stain or damage some fabrics or surfaces

OCTINOXATE FREE, OXYBENZONE FREE

*This product is not manufactured or distributed by Sun Bum ® LLC, distributor of Sun Bum Premium Moisturizing Sunscreen Lotion Broad Spectrum SPF 50.

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIGDE

GOODLETTSVILLE, TN 37072

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(888) 309-9030

Principal Display Panel

STUDIO SELECTION  ®

SUN

SUNSCREEN LOTION

Broad Spectrum SPF 50

Compare to Sun Bum ® Sunscreen Lotion Broad Spectrum SPF 50*

SPF 50

Dermatologist-Tested

Hypoallergenic

Water-Resistant (80 minutes)

Banana Scent

6 FL OZ (177 mL)

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.