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

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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Sachet Active Argan 02.3 Plasma Pro 50+ Featherweight Day Cream Broad Spectrum SPF 20 With Proprietary A.P.I. and Activated Argan Complex

Drug Facts

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

• 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

Label1Label

SACHET ACTIVE ARGAN 02.3 PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. AND ACTIVATED ARGAN COMPLEX 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70803-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION140 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 AP (UNII: F1X8L2B00J)  
CERAMIDE 3 (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70803-500-011 in 1 PACKAGE12/08/201610/03/2018
12 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/08/201610/03/2018
Labeler - Siborg (102875148)

Revised: 12/2019
 
Siborg