PIXI SUN SERUM SPF 30- avobenzone, octinoxate, octisalate, oxybenzone cream

PIXI SUN SERUM SPF 30 by

Drug Labeling and Warnings

PIXI SUN SERUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by PIXI, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE (7.5%)

OXYBENZONE (6%)

OCTISALATE (5%)

AVOBENZONE (1%)

PURPOSE

SUNSCREEN

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

FOR EXTERNAL USE ONLY.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

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.

IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS.
• CHILDREN UNDER 6 MONTHS. 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
• LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM - 2 PM
• WEAR LONG-SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES

CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

INACTIVE INGREDIENTS

AQUA (WATER), CAPRYLIC/CAPRIC TRIGLYCERIDE, CORN STARCH MODIFIED, CETEARYL OLIVATE, DIETHYLHEXYL 2,6-NAPHTHALATE, C12-15 ALKYL BENZOATE, SORBITAN OLIVATE, GLUCONOLACTONE, SQUALANE, GLYCERIN, CYCLOPENTASILOXANE, TOCOPHERYL ACETATE (D-ALPHA), GLYCINE SOJA (SOYBEAN) OIL, SODIUM HYALURONATE (L), XANTHAN GUM, CARBOMER, AMINOMETHYL PROPANOL, SODIUM BENZOATE, PHENETHYL ALCOHOL, CAPRYLYL CLYCOL, PHENOXYETHANOL, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, POTASSIUM SORBATE. MADE IN USA.

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS OR COMMENTS?

CALL TOLL FREE 1-800-792-5330

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PIXI SUN SERUM SPF 30 
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70686-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SORBITAN OLIVATE (UNII: MDL271E3GR)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SOYBEAN OIL (UNII: 241ATL177A)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70686-102-91	1 in 1 CARTON	08/03/2016
1	NDC: 70686-102-21	30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/03/2016

Labeler - PIXI, INC (830752593)

Registrant - PIXI, INC (830752593)