BB SPF-15- octinoxate, titanium dioxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (0.9%), TITANIUM DIOXIDE (12.2%)

Available from:

ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS)

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

SUNSCREEN - moderate protection against sunburn. - higher SPF gives more sunburn protection.

Authorization status:

OTC monograph final

Summary of Product characteristics

BB SPF-15- OCTINOXATE, TITANIUM DIOXIDE CREAM
ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS)
_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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ACTIVE INGREDIENTS
OCTINOXATE (0.9%)
TITANIUM DIOXIDE (12.2%)
PURPOSE
SUNSCREEN
USES
moderate protection against sunburn.
higher SPF gives more sunburn protection.
WARNINGS
For external use only
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor • if skin rash occurs.
Keep out of reach of children.
DIRECTIONS
• Apply generously 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor
Sun Protection Measures: Spending time in the sun increases your risk
of skin cancer and early skin
aging. To decrease this risk, regularly use a sunscreen with a Broad
Spectrum SPF value of 15 or
higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2 p.m. [bullet]
wear long-sleeved shirts, pants, hats, and
sunglasses".
INACTIVE INGREDIENTS
WATER/AQUA, CYCLOPENTASILOXANE, BUTYL GLYCOL, DIMETHICONE,
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE/VINYL
DIMETHICONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, DISTEARDIMONIUM
HECTORITE, SILICA, SODIUM CHLORIDE, HYDROLYZED CORALLINA OFFICINALIS
EXTRACT, TOCOPHERYL ACETATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, BHT,
TRIETHOXYCAPRYLYSILANE
MAY CONTAIN: TITANIUM DIOXIDE(CI 77891), IRON OXIDES(Cl 77492, Cl
77491, Cl 77499)
BB SPF-15
octinoxate, titanium dioxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 474-130
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
0 .9 g in 10 0 mL
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
TITANIUM DIOXIDE
12.2 g in 1