IPKN MOIST AND FIRM BB 03 LIGHT MEDIUM- titanium dioxide, octinoxate, octisalate, zinc oxide 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), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Inel Cosmetics Co., Ltd.

INN (International Name):

TITANIUM DIOXIDE

Composition:

TITANIUM DIOXIDE 4.02 mg in 40 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen For sunscreen use: - Apply liberally 15 minutes before sun exposure - Reapply at least every two hours - Use a water resistant sunscreen if swimming or sweating

Authorization status:

OTC monograph not final

Summary of Product characteristics

IPKN MOIST AND FIRM BB 03 LIGHT MEDIUM- TITANIUM DIOXIDE, OCTINOXATE,
OCTISALATE, ZINC
OXIDE CREAM
INEL 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._
----------
DRUG FACTS
Titanium Dioxide 10.05%
Octinoxate 7.00%
Octisalate 4.70%
Zinc Oxide 3.48%
Sunscreen
For sunscreen use:
- Apply liberally 15 minutes before sun exposure
- Reapply at least every two hours
- Use a water resistant sunscreen if swimming or sweating
If rash or irritation occurs, stop use and ask a doctor.
When using this product, keep out of eyes. Rinse with water to remove.
Water
Cyclomethicone 5
Glycerin
Talc
Peg-10 dimethicone (600 cst)
Ferric oxide yellow
dipropylene glycol
hexyl laurate
isoeicosane
niacinamide
cyclomethicone
distearlydimonium
magnesium sulfate
ferric oxide red
c12 - 14 Pareth-3
phenoxyethanol
methicone (20 cst)
Aluminum hydroxide
aluminum stearate
palmitic acid
ferrosoferric oxide
betaine
ethylhexylglycerin
.alpha.-tocopherol acetate
treithoxycaprylylsilane
dimethicone
adenosine
polymethylsilsesquiopxane (4.5 microns)
ceramide 3
gold
butylene glycol
prunus serrulata flower
ehyl methane carboxamide
IPKN MOIST AND FIRM BB 03 LIGHT MEDIUM
titanium dioxide, octinoxate, octisalate, zinc oxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:43526 -10 8
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
4.0 2 mg in 40 mL
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
2.8 mg in 40 mL
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
1.8 8 mg in 40 mL
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
1.39 2 mg in 40 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CYC