ATOMY SUN CREAM SPF 50 PA - octinoxate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

ATOMY CO LTD

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 4.5 mL in 60 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

ATOMY SUN CREAM SPF 50 PA - OCTINOXATE CREAM
ATOMY 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._
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ATOMY SUNCREAM SPF 50+PA+++
DRUG FACTS
Active ingredients
Octinoxate 7.5%
Octisalate 5.0%
Zinc Oxide 4.9%
Titanium Dioxide 2.49%
Uses
Helps prevent sunburn. Provides High protect from sunburn. Highter SPF
gives more sunburn
protection.
Directions
Apply after basic skin care product. Spread and appropriate amount
entire face following the skin
texture. Reapply as required.
Warnings
For external use only.
UV exposure from the sun increases the risk of skin cancer, premature
skin aging, and other skin
damage. It is important to decrease UV exposure by limiting time in
the sun, wearing protective
clothing, and using a sunscreen.
When using the product Keep out of eyes. Rinse with water to remove.
Keep out of reach of children if swallowed, get medical help or
contact a Poison Control Center
ATOMY SUNCREAM SPF 50+PA+++
60ml/2fl.oz
ATOMY CO LTD
ATOMY SUN CREAM SPF 50 PA
octinoxate cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:52257-10 0 1
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
4.5 mL in 6 0 mL
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
3 mL in 6 0 mL
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
2.9 mL in 6 0 mL
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
TITANIUM DIOXIDE
1.5 mL in 6 0 mL
PRODUCT CHARACTERISTICS
COLOR
yello w (yello w bro wn)
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:52257-10 0 1-2
1 in 1 BOX
1
NDC:52257-10 0 1-1
6 0 mL in 1 TUBE
MARKETING INFORMATION
MARKE TING CA