FIRMING DAY SPF 30- zinc oxide octinoxate cream

FIRMING DAY by

Drug Labeling and Warnings

FIRMING DAY by is a Otc medication manufactured, distributed, or labeled by CEN BEAUTY LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

ZINC OXIDE 15%

OCTINOXATE 6%

PURPOSE

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

USES

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

DO NOT USE

• On damaged or broken skin

WHEN USING

WHEN USING THIS PRODUCT

• Keep out of eyes. Rinse with water to remove.

STOP USE

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS

• Apply on to clean and dry face morning and night, avoiding the delicate eye area.
• Apply 15 minutes before sun exposure. May be used daily.
• Consult your physician before use.

OTHER SAFETY INFORMATION

Other Information

• STORE AT 15-30°C (59-86°F)
• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENT

INGREDIENTS

aqua (water), cyclopentasiloxane, PEG-10 dimethicone, dimethicone, butylene glycol, cyclohexasiloxane, glycerin, carollina officinalis extract, algae extract, avena sativa (oat) kernel extract, angelica sinensis extract, 10-hydroxydecanoic acid, sebacic acid, 1,10-decanediol acid, betaine, dimethicone/vinyl dimethicone crosspolymer, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, lecithin, dimethicone/PEG-10/15 crosspolymer, triethoxycaprylylsilane, decamethylcyclopentasiloxane, trifluoromethyl C1-C4 alkyl dimethicone, quaternium-90, bentonite, butylene glycol, sodium chloride, sodium citrate, ethylhexylglycerin, propylene carbonate, propylene glycol, potassium sorbate, methylisothiazolinone, iodopropynyl butylcarbamate, phenoxyethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRMING DAY  SPF 30
zinc oxide octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54272-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
CORALLINA OFFICINALIS (UNII: 4004498D06)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
OAT (UNII: Z6J799EAJK)
ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)
10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)
SEBACIC ACID (UNII: 97AN39ICTC)
1,10-DECANEDIOL (UNII: 5I577UDK52)
BETAINE (UNII: 3SCV180C9W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)
2,2,2-TRIFLUOROACETOPHENONE (UNII: 6T7L1UPY09)
QUATERNIUM-91 (UNII: 00J8H295NB)
BENTONITE (UNII: A3N5ZCN45C)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54272-202-11	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/21/2013

Labeler - CEN BEAUTY LLC (078664118)

Registrant - CEN BEAUTY LLC (078664118)