NDC 13537-089

LBEL Hydra Calme

Octinoxate, Octisalate, And Oxybenzone

LBEL Hydra Calme is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Ventura International Ltd. The primary component is Octinoxate; Octisalate; Oxybenzone.

Product ID13537-089_c71a5af0-420c-49cf-a28d-46d2224f10cf
NDC13537-089
Product TypeHuman Otc Drug
Proprietary NameLBEL Hydra Calme
Generic NameOctinoxate, Octisalate, And Oxybenzone
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2010-08-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameVentura International LTD
Substance NameOCTINOXATE; OCTISALATE; OXYBENZONE
Active Ingredient Strength0 mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 13537-089-53

1 JAR in 1 BOX (13537-089-53) > 1 mL in 1 JAR (13537-089-52)
Marketing Start Date2010-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13537-089-52 [13537008952]

LBEL Hydra Calme LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-08-15

NDC 13537-089-53 [13537008953]

LBEL Hydra Calme LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-08-15
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE.075 mg/mL

OpenFDA Data

SPL SET ID:8b89dfc4-2345-4329-9ace-957de14e5a81
Manufacturer
UNII

NDC Crossover Matching brand name "LBEL Hydra Calme" or generic name "Octinoxate, Octisalate, And Oxybenzone"

NDCBrand NameGeneric Name
65643-333Bellagio Lip Moisturizer SPF 15Octinoxate, Octisalate, and Oxybenzone
11410-839Ice ElementsOctinoxate, Octisalate, and Oxybenzone
52854-932Land Shark SPF 30octinoxate, octisalate, and oxybenzone
13537-031LBELOctinoxate, Octisalate, and Oxybenzone
13537-088LBELOctinoxate, Octisalate, and Oxybenzone
13537-089LBELOctinoxate, Octisalate, and Oxybenzone
14783-077LBelOctinoxate, Octisalate, and Oxybenzone
14783-400LBELOctinoxate, Octisalate, and Oxybenzone
14783-035LBel ParisOctinoxate, Octisalate, and Oxybenzone
14783-045LBel ParisOctinoxate, Octisalate, and Oxybenzone
14783-055LBel ParisOctinoxate, Octisalate, and Oxybenzone
72102-047Maketa Sunscreen with Aloe Vera SPF 30Octinoxate, Octisalate, and Oxybenzone
58443-0107MAX BLOCKOctinoxate, Octisalate, and Oxybenzone
58443-0108MAX BLOCKOctinoxate, Octisalate, and Oxybenzone
58443-0109MAX BLOCKOctinoxate, Octisalate, and Oxybenzone
58443-0112MAX BLOCKOctinoxate, Octisalate, and Oxybenzone
70605-008Meaningful Beauty BB Broad Spectrum SPF 15 (Light, Medium, Dark)OCTINOXATE, OCTISALATE, and OXYBENZONE
58443-0046Panama JackOctinoxate, Octisalate, and Oxybenzone
58443-0055Panama JackOctinoxate, Octisalate, and Oxybenzone
11410-206Proactiv Sheer Tint MoistureOCTINOXATE, OCTISALATE, and OXYBENZONE
11410-711Proactiv Sheer Tint MoistureOCTINOXATE, OCTISALATE, and OXYBENZONE
11410-001Proactiv Solution BB Broad Spectrum SPF 15 (Light, Medium, Dark)OCTINOXATE, OCTISALATE, and OXYBENZONE
70605-042Reclaim Revolutionary Anti-Aging Day SPF15Octinoxate, Octisalate, and Oxybenzone
11410-694Sheer Cover Nourishing MoisturizerOCTINOXATE, OCTISALATE, and OXYBENZONE
70605-024Sheer Cover Nourishing MoisturizerOCTINOXATE, OCTISALATE, and OXYBENZONE
59427-111SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20OCTINOXATE, OCTISALATE, and OXYBENZONE
71627-116Sunscreen with Aloe Vera SPF 30Octinoxate, Octisalate, and Oxybenzone
73563-011Sunscreen with Aloe Vera SPF 30Octinoxate, Octisalate, and Oxybenzone
58443-0126UltaOctinoxate, Octisalate, and Oxybenzone
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