HYDRATING FACIAL SPF-30- avobenzone, meradimate, octinoxate, octisalate lotion

HYDRATING FACIAL by

Drug Labeling and Warnings

HYDRATING FACIAL by is a Otc medication manufactured, distributed, or labeled by VU SKIN SYSTEM, INC., Chemolee Lab Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE (3%)

MERADIMATE (5%)

OCTINOXATE (7.5%)

OCTISALATE (5%)

PURPOSE

SUN PROTECTION

INDICATIONS

THIS EXCLUSIVE FORMULATION PROVIDES A HIGH DEGREE OF SUN PROTECTION AGAINST BOTH UVA AND UBV RADIATION.

WARNINGS

WHEN USING THIS PRODUCT, KEEP OUT OF EYES, RINSE WITH WATER TO REMOVE. IF RASH OR IRRITATION DEVELOPS AND PERSISTS, SEE A DERMATOLOGIST OR PHYSICIAN. AVOID USE IN CHILDREN UNDER 6 MONTHS OF AGE.

DIRECTIONS

APPLIED DAILY AS A FACIAL MOISTURIZER FOR BOTH UVA AND UVB PROTECTION. WILL NOT CLOG PORES. NOTE UVA IS EMITTED FROM THE ATMOSPHERE ALL YEAR LONG! REAPPLY AFTER TOWEL DRYING, SWIMMING, SWEATING OR THREE HOURS IN HOT SUNLIGHT.

SUN PROTECTIO FACTOR:  30

sUN ALERT: USING A BROAD SPECTRUM SPF 30 MAY REDUCE THE RISK OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL EFFECTS.

INGREDIENTS

ALOE BARBADENSIS LEAF JUICE, WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, STEARYL ALCOHOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERYL STEARATE, TOCOPHERYL ACETATE, CARBOMER, ALLANTOIN, PANTHENOL, SODIUM LAURYL SULFATE, TRIETHANOLAMINE, TETRASODIUM EDTA, FRAGRANCE, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRATING FACIAL  SPF-30
avobenzone, meradimate, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71264-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	5 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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 934 (UNII: Z135WT9208)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71264-101-14	105 mL in 1 TUBE; Type 0: Not a Combination Product	02/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/07/2016

Labeler - VU SKIN SYSTEM, INC. (930729848)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(71264-101)