NDC 14783-400

LBEL Hydra Calme SPF 15

Octinoxate, Octisalate, And Oxybenzone

LBEL Hydra Calme SPF 15 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 ID: 14783-400_da6ec481-b844-411c-a101-1b8eae6c6c1e
• NDC: 14783-400
• Product Type: Human Otc Drug
• Proprietary Name: LBEL Hydra Calme SPF 15
• Generic Name: Octinoxate, Octisalate, And Oxybenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-09-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Ventura International Ltd.
• Substance Name: OCTINOXATE; OCTISALATE; OXYBENZONE
• Active Ingredient Strength: 0 g/mL; g/mL; g/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 14783-400-02

1 TUBE in 1 BOX (14783-400-02) > 50 mL in 1 TUBE (14783-400-01)

• Marketing Start Date: 2011-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 14783-400-03 [14783040003]

LBEL Hydra Calme SPF 15 LOTION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-09-01

NDC 14783-400-05 [14783040005]

LBEL Hydra Calme SPF 15 LOTION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-09-01
• Inactivation Date: 2019-10-29

NDC 14783-400-02 [14783040002]

LBEL Hydra Calme SPF 15 LOTION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-09-01
• Inactivation Date: 2019-10-29

NDC 14783-400-04 [14783040004]

LBEL Hydra Calme SPF 15 LOTION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-09-01
• Inactivation Date: 2019-10-29

NDC 14783-400-01 [14783040001]

LBEL Hydra Calme SPF 15 LOTION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-09-01

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	.075 g/mL

OpenFDA Data

• SPL SET ID: 92761513-d108-454a-8ae4-6b06ef12c6d8
• Manufacturer:
  • Ventura International Ltd.
• UNII:
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51

NDC Crossover Matching brand name "LBEL Hydra Calme SPF 15" or generic name "Octinoxate, Octisalate, And Oxybenzone"

NDC	Brand Name	Generic Name
65643-333	Bellagio Lip Moisturizer SPF 15	Octinoxate, Octisalate, and Oxybenzone
11410-839	Ice Elements	Octinoxate, Octisalate, and Oxybenzone
52854-932	Land Shark SPF 30	octinoxate, octisalate, and oxybenzone
13537-031	LBEL	Octinoxate, Octisalate, and Oxybenzone
13537-088	LBEL	Octinoxate, Octisalate, and Oxybenzone
13537-089	LBEL	Octinoxate, Octisalate, and Oxybenzone
14783-077	LBel	Octinoxate, Octisalate, and Oxybenzone
14783-400	LBEL	Octinoxate, Octisalate, and Oxybenzone
14783-035	LBel Paris	Octinoxate, Octisalate, and Oxybenzone
14783-045	LBel Paris	Octinoxate, Octisalate, and Oxybenzone
14783-055	LBel Paris	Octinoxate, Octisalate, and Oxybenzone
72102-047	Maketa Sunscreen with Aloe Vera SPF 30	Octinoxate, Octisalate, and Oxybenzone
58443-0107	MAX BLOCK	Octinoxate, Octisalate, and Oxybenzone
58443-0108	MAX BLOCK	Octinoxate, Octisalate, and Oxybenzone
58443-0109	MAX BLOCK	Octinoxate, Octisalate, and Oxybenzone
58443-0112	MAX BLOCK	Octinoxate, Octisalate, and Oxybenzone
70605-008	Meaningful Beauty BB Broad Spectrum SPF 15 (Light, Medium, Dark)	OCTINOXATE, OCTISALATE, and OXYBENZONE
58443-0046	Panama Jack	Octinoxate, Octisalate, and Oxybenzone
58443-0055	Panama Jack	Octinoxate, Octisalate, and Oxybenzone
11410-206	Proactiv Sheer Tint Moisture	OCTINOXATE, OCTISALATE, and OXYBENZONE
11410-711	Proactiv Sheer Tint Moisture	OCTINOXATE, OCTISALATE, and OXYBENZONE
11410-001	Proactiv Solution BB Broad Spectrum SPF 15 (Light, Medium, Dark)	OCTINOXATE, OCTISALATE, and OXYBENZONE
70605-042	Reclaim Revolutionary Anti-Aging Day SPF15	Octinoxate, Octisalate, and Oxybenzone
11410-694	Sheer Cover Nourishing Moisturizer	OCTINOXATE, OCTISALATE, and OXYBENZONE
70605-024	Sheer Cover Nourishing Moisturizer	OCTINOXATE, OCTISALATE, and OXYBENZONE
59427-111	SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20	OCTINOXATE, OCTISALATE, and OXYBENZONE
71627-116	Sunscreen with Aloe Vera SPF 30	Octinoxate, Octisalate, and Oxybenzone
73563-011	Sunscreen with Aloe Vera SPF 30	Octinoxate, Octisalate, and Oxybenzone
58443-0126	Ulta	Octinoxate, Octisalate, and Oxybenzone