Is OraLabs, Inc. FDA approved?

OraLabs, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are OraLabs, Inc.'s drugs manufactured?

The FDA register lists Parker, CO. Registered operations: analytical testing, labelling, finished drug manufacture.

What drugs does OraLabs, Inc. make?

18 products are listed under OraLabs, Inc. in the openFDA NDC Directory, most often as stick; spray. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

OraLabs, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 18
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
OraLabs, IncRegistrant: OraLabs, Inc.	18685 East Plaza Drive, Parker, Colorado (CO) 80134, United States (USA)	Analytical testing, Labelling, Finished drug manufacture	3001237145801824756

Catalogue

Drug listings by form and route

18 active NDC listings: 18 human otc drug. By marketing category: OTC MONOGRAPH DRUG 18.

Dosage form	NDCs
stick	15
spray	3

Route	NDCs
topical	18

Labeller name on the listing	NDCs
oralabs	18

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
CPH Anti-bacterial Breath Mist	Cetylpyridinium chloride	spray, topical	63645-179OTC MONOGRAPH DRUG
ChapIce Moisture SPF 15 Lip Balm	Oxybenzone, Octinoxate, Petrolatum	stick, topical	63645-140OTC MONOGRAPH DRUG
ChapIce SPF 30 Lip Balm	Octinoxate, Octocrylene, Oxybenzone, Octisalate	stick, topical	63645-163OTC MONOGRAPH DRUG
ChapIce SPF 30 Lip Balm	Octinoxate, Octocrylene, Oxybenzone, Octisalate	stick, topical	63645-164OTC MONOGRAPH DRUG
ChapIce SPF 30 Lip Balm	Avobenzone, Octisalate, Homosalate, Petrolatum	stick, topical	63645-180OTC MONOGRAPH DRUG
Healing Balm Skin Protectant	Petrolatum	stick, topical	63645-185OTC MONOGRAPH DRUG
OraLabs ChapIce Cherry Petrolatum	Petrolatum	stick, topical	63645-170OTC MONOGRAPH DRUG
OraLabs ChapIce Original Petrolatum	Petrolatum	stick, topical	63645-169OTC MONOGRAPH DRUG
OraLabs SPF 15 Lip Balm	Avobenzone, Octinoxate, Petrolatum	stick, topical	63645-181OTC MONOGRAPH DRUG
SPF 15 - Zinc Oxide Lip Balm	Zinc Oxide	stick, topical	63645-182OTC MONOGRAPH DRUG
SPF 30 - Zinc Oxide Lip Balm	Zinc Oxide	stick, topical	63645-184OTC MONOGRAPH DRUG
SPF 30 Sunscreen Stick	Avobenzone, Homosalate, Octisalate, Octocrylene	stick, topical	63645-329OTC MONOGRAPH DRUG
SPF 45 - Lip Balm	Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum	stick, topical	63645-183OTC MONOGRAPH DRUG
SPF 50 Sunscreen Stick	Zinc Oxide	stick, topical	63645-178OTC MONOGRAPH DRUG
Sanell Hand Sanitizer	Alcohol	spray, topical	63645-174OTC MONOGRAPH DRUG
Sanell Hand Sanitizer	Alcohol	spray, topical	63645-177OTC MONOGRAPH DRUG
Sunfrog Ultra SPF 30 Lip Balm	Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly	stick, topical	63645-165OTC MONOGRAPH DRUG
Tea Tree Lip Balm, SPF 15	Octinoxate, Oxybenzone	stick, topical	63645-176OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is OraLabs, Inc. FDA approved?: OraLabs, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are OraLabs, Inc.'s drugs manufactured?: The FDA register lists Parker, CO. Registered operations: analytical testing, labelling, finished drug manufacture.
What drugs does OraLabs, Inc. make?: 18 products are listed under OraLabs, Inc. in the openFDA NDC Directory, most often as stick; spray. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.