NDC 42421-600

Fre Broad Spectrum

Avobenzone, Homosalate, Octisalate, Octocrylene

Fre Broad Spectrum is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Emilia Personal Care Inc. The primary component is Avobenzone; Homosalate; Octisalate; Octocrylene.

Product ID42421-600_2fdb6110-2b28-4e1f-b280-416c529921d1
NDC42421-600
Product TypeHuman Otc Drug
Proprietary NameFre Broad Spectrum
Generic NameAvobenzone, Homosalate, Octisalate, Octocrylene
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-06-28
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameEmilia Personal Care Inc
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active Ingredient Strength2 g/60mL; g/60mL; g/60mL; g/60mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42421-600-20

20 mL in 1 TUBE (42421-600-20)
Marketing Start Date2018-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42421-600-20 [42421060020]

Fre Broad Spectrum CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-13
Inactivation Date2020-01-31
Reactivation Date2020-05-18

NDC 42421-600-60 [42421060060]

Fre Broad Spectrum CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-28
Inactivation Date2020-01-31
Reactivation Date2020-05-18

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE1.8 g/60mL

OpenFDA Data

SPL SET ID:aeb0b914-db57-4c32-adf1-b6d0b355b3ab
Manufacturer
UNII

NDC Crossover Matching brand name "Fre Broad Spectrum" or generic name "Avobenzone, Homosalate, Octisalate, Octocrylene"

NDCBrand NameGeneric Name
42421-600Fre Broad SpectrumFre Broad Spectrum
0869-0714Avobenzone, Homosalate, Octisalate, OctocryleneAvobenzone, Homosalate, Octisalate, Octocrylene
0869-0769Avobenzone, Homosalate, Octisalate, OctocryleneAvobenzone, Homosalate, Octisalate, Octocrylene
0299-4113Cetaphil Daily Facial Moisturizer with suncreen SPF 35avobenzone, homosalate, octisalate, octocrylene
0299-4118Cetaphil Healthy Radiance Whipped Day Cream Broad Spectrum SPF 30avobenzone, homosalate, octisalate, octocrylene
10356-328Eucerin Daily HydrationAvobenzone, Homosalate, Octisalate, Octocrylene
10356-335Eucerin Daily HydrationAvobenzone, Homosalate, Octisalate, Octocrylene
10356-331Eucerin Daily Hydration HandAvobenzone, Homosalate, Octisalate, Octocrylene
0924-0801First Aid Only SunX30 SunscreenAvobenzone, Homosalate, Octisalate, Octocrylene
0363-0540Hydrating Antioxidant MoiturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
0869-0055SunscreenAvobenzone, Homosalate, Octisalate, Octocrylene
0869-0109SunscreenAvobenzone, Homosalate, Octisalate, Octocrylene
0869-0940SunscreenAvobenzone, Homosalate, Octisalate, Octocrylene
0363-8227WALG SUN MOIST SPF50Avobenzone, Homosalate, Octisalate, Octocrylene
0363-8223WALG SUN MOISTURIZING SPF 50Avobenzone, Homosalate, Octisalate, Octocrylene
0363-0943WALGREENS BROAD SPECTRUM SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
0363-0965Walgreens Dry Touch Broad Spectrum SPF 55Avobenzone, Homosalate, Octisalate, Octocrylene
0363-0135WALGREENS SPF 100 SHEER BODY SUNSCREEN MISTAvobenzone, Homosalate, Octisalate, Octocrylene
0363-0093Walgreens SPF 30 SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
0363-0066Walgreens SPF 50 Clear Complexion Face SunscreenAvobenzone, Homosalate, Octisalate, Octocrylene
0363-0090Walgreens SPF 50 Sport FacesAvobenzone, Homosalate, Octisalate, Octocrylene
0363-0053Walgreens SPF 55 Sheer Face Mist SunscreenAvobenzone, Homosalate, Octisalate, Octocrylene
0363-0976Walgreens SPF55 Sunscreen Reef-Conscious FormulaAvobenzone, Homosalate, Octisalate, Octocrylene
0363-0997WALGREENS SPORT CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
0363-0924WALGREENS SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
0363-0925WALGREENS SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
0363-9921Walgreens Sun Kids SPF50avobenzone, homosalate, octisalate, octocrylene
0363-9924Walgreens Sun Kids SPF50avobenzone, homosalate, octisalate, octocrylene
0363-4013Walgreens sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
0363-9362Walgreens Wrinkle Repair Moisturizer SPF30Avobenzone, Homosalate, Octisalate, Octocrylene
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