CB 102- spf 15 lip balm lipstick

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Available from:
Tekweld Solutions, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Octinoxate ..............................Sunscreen Oxybenzone ...........................Sunscreen Uses: - Helps prevent sunburn • Do not use on broken skin • Stop use and ask doctor : if rash or irritation develops and persists.
Authorization status:
OTC monograph final
Authorization number:
71160-192-01

CB 102- spf 15 lip balm lipstick

Tekweld Solutions, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

SPF 15

Drug Facts

Active ingredients:

Octinoxate 7.5%

Oxybenzone 3.0%

Purpose:

Octinoxate ..............................Sunscreen

Oxybenzone ...........................Sunscreen

Us es :

Helps prevent sunburn

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.

For external use only.

Do not use on broken skin

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

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

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

right away.

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 Ingredients

Petrolatum, Paraffin, Mineral Oil, Theobroma Cacao (Cocoa) Seed Butter,

Zea Mays (Corn) Oil, Glycine Soja (Soybean) Oil, Tocopherol, Simmondisa

Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Retinyl

Palmitate, Aloe Barbadensis Leaf Extract, BHA, Propyl Gallate, Citric Acid,

Cholecalciferol.

Other information

Protect this product from excessive heat and direct sun

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

CB 102

spf 15 lip balm lipstick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7116 0 -19 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

0 .318 75 g in 4.25 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

0 .1275 g in 4.25 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

PARAFFIN (UNII: I9 O0 E3H2ZE)

MINERAL O IL (UNII: T5L8 T28 FGP)

CO CO A BUTTER (UNII: 512OYT1CRR)

CO RN O IL (UNII: 8 470 G57WFM)

SO YBEAN O IL (UNII: 241ATL177A)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

JO JO BA O IL (UNII: 724GKU717M)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)

PRO PYL GALLATE (UNII: 8 D4SNN7V9 2)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

CHO LECALCIFERO L (UNII: 1C6 V77QF41)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7116 0 -19 2-0 1

4.25 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 8 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 4/0 8 /20 19

Labeler -

T ekweld Solutions, Inc. (029077754)

Registrant -

T ekweld Solutions, Inc. (029077754)

Tekweld Solutions, Inc.

Revised: 4/2019

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