NDC 68634-050

Sheltered Broad Spectrum SPF 55 Sunscreen

Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene

Sheltered Broad Spectrum SPF 55 Sunscreen is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Amcol Health & Beauty Solutions, Inc. Dba. The primary component is Homosalate; Oxybenzone; Octisalate; Avobenzone; Octocrylene.

Product ID68634-050_8cc522b4-c4f9-40f6-b24c-f58ea9eb8b0c
NDC68634-050
Product TypeHuman Otc Drug
Proprietary NameSheltered Broad Spectrum SPF 55 Sunscreen
Generic NameHomosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2015-09-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameAMCOL Health & Beauty Solutions, Inc. DBA
Substance NameHOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active Ingredient Strength100 g/mL; g/mL; g/mL; g/mL; g/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68634-050-01

1 BOTTLE in 1 CARTON (68634-050-01) > 50 mL in 1 BOTTLE
Marketing Start Date2015-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68634-050-01 [68634005001]

Sheltered Broad Spectrum SPF 55 Sunscreen LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-09-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HOMOSALATE100 g/mL

OpenFDA Data

SPL SET ID:c8d1be79-a585-4e04-ade2-4ee6d8e962a6
Manufacturer
UNII

NDC Crossover Matching brand name "Sheltered Broad Spectrum SPF 55 Sunscreen" or generic name "Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene"

NDCBrand NameGeneric Name
68634-050Sheltered Broad Spectrum SPF 55 Sunscreenhomosalate, oxybenzone, octisalate, avobenzone, octocrylene
10096-0294Avon SunHomosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene
10096-0295Avon SunHomosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene
10096-0313Avon Sun SportHomosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene
76144-232Paulas Choice Extra Care Non-Greasy Sunscreen SPF 50Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene
10056-706Peter Island Baby SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
50390-706Peter Island Baby SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
10056-701Peter Island Continuous Sport SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
50390-701Peter Island Continuous Sport SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
50390-703Peter Island Kids SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
10056-704Peter Island SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
10056-705Peter Island SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
50390-702Peter Island SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
50390-704Peter Island SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
50390-705Peter Island SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
10056-702Peter Island SunscreenSPF 50HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
10056-707Peter Island Ultimate Sheer Dry Touch SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
50390-707Peter Island Ultimate Sheer Dry Touch SunscreenHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
68634-053SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Facehomosalate, oxybenzone, octisalate, avobenzone, octocrylene
69842-021SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Facehomosalate, oxybenzone, octisalate, avobenzone, octocrylene
0363-4010Walgreens Sunscreen BabyHOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
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