CB 101- spf 15 lip balm lipstick

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

MAH:

Tekweld Solutions, Inc.

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

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

SPC

CB 101- 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 3.5%
_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, Ozokerite, Mineral Oil, Microcrystalline Wax, Paraffin,
Lanolin,
Copernicia Cerifera (Carnauba) Wax, Tocopherol,
Propylparaben, Methylparaben, Aloe Barbadensis Leaf Extract.
_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
Tekweld Solutions, Inc.
res
CB 101
spf 15 lip balm lipstick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7116 0 -19 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXAT