SUN SCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide lotion

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), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Available from:

Webb Business Promotions

INN (International Name):

TITANIUM DIOXIDE

Composition:

TITANIUM DIOXIDE 4 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Sun Screen

Authorization status:

OTC monograph final

Summary of Product characteristics

SUN SCREEN- OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
LOTION
WEBB BUSINESS PROMOTIONS
_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._
----------
1OZ SPF 30 SUNSCREEN LOTION
PURPOS E
PURPOS E
Sun Screen
DRUG FACTS
Octinoxate 7.0%
Octisalate 4.0%
Titanium Dioxide 4.0%
Benzophenone 3.0%
DIRECTIONS
WARNINGS
INACTIVE INGREDIENTS
SPF 30 SUNSCREEN LOTION-1OZ ASI95838
MADE IN CHINA
SUN SCREEN
octinoxate, octisalate, oxybenzone, titanium dioxide lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 445-158
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
TITANIUM DIOXIDE
4 g in 10 0 g
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
7 g in 10 0 g
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
4 g in 10 0 g
O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)
OXYBENZONE
3 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
Webb Business Promotions
PRO PYLPARABEN (UNII: Z8 IX2SC1OH)
GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)
CETETH-2 5 (UNII: 5KLY4IOG20 )
CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6 M2JG9 )
GLYCERIN (UNII: PDC6 A3C0 OX)
ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)
ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)
WATER (UNII: 0 59 QF0 KO0 R)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70 445-158 -
0 1
5 g in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n
Pro duc t
0 9 /11/20 0 9
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH C