CB 101- spf 15 lip balm lipstick

CB 101 by

Drug Labeling and Warnings

CB 101 by is a Otc medication manufactured, distributed, or labeled by Tekweld Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients:
Octinoxate 7.5%
Oxybenzone 3.5%

PURPOSE

Purpose:
Octinoxate ..............................Sunscreen
Oxybenzone ...........................Sunscreen

INDICATIONS & USAGE

Uses:

• Helps prevent sunburn

WARNINGS

Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your
risk of skin cancer and early skin aging. This product has been shown
only to help prevent sunburn, not skin cancer or early skin aging.

OTHER SAFETY INFORMATION

For external use only.

DO NOT USE

Do not use on broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask doctor: if rash or irritation develops and persists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
Apply liberally 15 minutes before sun exposure as needed
Children under 6 months of age: ask a doctor before use.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENT

Inactive Ingredients
Petrolatum, Ozokerite, Mineral Oil, Microcrystalline Wax, Paraffin, Lanolin,
Copernicia Cerifera (Carnauba) Wax, Tocopherol,
Propylparaben, Methylparaben, Aloe Barbadensis Leaf Extract.

OTHER SAFETY INFORMATION

Other information
Protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments? www.tekweld.com                MADE IN USA

Product Package

SPF15 Natural Aloe Vera Safety Sealed

Peel Back for Drug Facts

Net Wt. 0.15 oz (4.25g)
Distributed by: Tekweld 45 Rabro Dr. Hauppauge, NY 11788

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INGREDIENTS AND APPEARANCE

CB 101 
spf 15 lip balm lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71160-191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.31875 g  in 4.25 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.14875 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
MINERAL OIL (UNII: T5L8T28FGP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
LANOLIN (UNII: 7EV65EAW6H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71160-191-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2019

Labeler - Tekweld Solutions, Inc. (029077754)

Registrant - Tekweld Solutions, Inc. (029077754)