NDC | 70803-500-01 |
Set ID | 432a5c8f-4cdb-0138-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Siborg |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active ingredients
- Uses
- Warnings
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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
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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
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INGREDIENTS AND APPEARANCE
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 creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70803-500 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70803-500-01 1 in 1 PACKAGE 12/08/2016 1 2 mL in 1 PACKET; 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 12/08/2016 Labeler - Siborg (102875148)