ACTIVE ARGAN 02.3(TM) PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. AND ACTIVATED ARGAN COMPLEX(TM)- zinc oxide cream

ACTIVE ARGAN 02.3(TM) PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. and ACTIVATED ARGAN COMPLEX(TM) by

Drug Labeling and Warnings

ACTIVE ARGAN 02.3(TM) PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. and ACTIVATED ARGAN COMPLEX(TM) by is a Otc medication manufactured, distributed, or labeled by SIBORG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc oxide 14%

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

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 rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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.
•    Wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

water (aqua) (*oxygen-rich purified water), dicaprylyl carbonate, dimethicone, glycerin, caprylic/capric triglyceride, cetyl PEG/PPG-10/1 dimethicone, phenyl trimethicone, cetyl dimethicone, sodium chloride, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, argania spinosa kernel oil (*specially-ozonized organic argan oil), tocopherol (*GMO-free vegetable vitamin E), wheat (triticum vulgare) germ oil, amyris balsamifera bark oil, tocopheryl acetate, ceramide 1, ceramide 6-II, ceramide 3, phytosphingosine, acacia decurrens/jojoba/sunflower seed wax/polyglyceryl-3 esters, triethoxycaprylylsilane, polyglyceryl-3 diisostearate, isopropyl myristate, BHT, carbomer, xanthan gum, sodium lauroyl lactylate, cholesterol, ethylhexylglycerin, fragrance (*100% natural fragrance), phenoxyethanol

Package Labeling:

INGREDIENTS AND APPEARANCE

ACTIVE ARGAN 02.3(TM) PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. AND ACTIVATED ARGAN COMPLEX(TM) 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70803-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	140 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ARGAN OIL (UNII: 4V59G5UW9X)
TOCOPHEROL (UNII: R0ZB2556P8)
WHEAT GERM OIL (UNII: 14C97E680P)
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE NP (UNII: 4370DF050B)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70803-023-50	1 in 1 BOX	12/01/2016
1		50 mL in 1 BOTTLE; 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	12/01/2016

Labeler - SIBORG (102875148)