TCS WEIGHTLESS BLEND EVERYDAY PRIMER- ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)

Available from:

Beyond Cosmetics co. , Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

helps prevent sunburn for external use only

Authorization status:

OTC monograph not final

Summary of Product characteristics

TCS WEIGHTLESS BLEND EVERYDAY PRIMER- ETHYLHEXYL METHOXYCINNAMATE,
TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE CREAM
BEYOND COSMETICS CO. , LTD
_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._
----------
ACTIVE INGREDIENT
ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate
INACTIVE INGREDIENT
water, dpropylene glycol, butylene glycol, etc
PURPOSE
helps prevent sunburn
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
WARNING
for external use only
do not use on damaged or broken skin
USES
for external use only
INDICATION & USAGE SECTION
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
TCS WEIGHTLESS BLEND EVERYDAY PRIMER
ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate
cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81677-0001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE -
UNII:15FIX9V2JP)
TITANIUM DIOXIDE
4.5 g in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
5 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
OCTISALATE
4 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Beyond Cosmetics co. , Ltd
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:81677-
0001-1
30 mL in 1 TUBE; Type 0: Not a Combination
Product
03/13/2021
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part352
03/13/2021
LABELER -
Beyond Cosmetics co. , Ltd (688425935)
REGISTRANT -
Beyond Cosmetics co. , Ltd (688425935)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Beyond Cosmetics co. , Ltd
688425935
manufacture(81677-0001)
Revised: 3/2021