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Name:Borba Pms Skin Rescue A.m. Spf 40 Plus Treatment
Manufacturer:Borba, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BORBA PMS SKIN RESCUE

BORBA PMS SKIN RESCUE  A.M. SPF 40 PLUS TREATMENT - titanium dioxide and zinc oxide lotion 
Borba, Inc.

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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BORBA
PMS SKIN RESCUE

Drug Facts

Active ingredient Purpose
Titanium Dioxide 2.5% Sunscreen
Zinc Oxide 2.1% Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides high protection against sunburn

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally and evenly 30 minutes before sun exposure
  • reapply as needed or after towel drying, swimming, or perspiring
  • children under 6 months of age: ask a doctor

Inactive ingredients

water, glycerin, butylene glycol, C12-15 alkyl benzoate, octyldodecanol, dimethicone, glyceryl stearate, propylene glycol dicaprylate/dicaprate, polysorbate 60, PVP, acetyl glucosamine, theobroma cacao (cocoa) seed butter, avena sativa (oat) kernel flour, sodium hyaluronate, fragaria vesca (strawberry) fruit extract, euterpe oleracea fruit extract, hydrolyzed elastin, hydrolyzed wheat protein, palmitoyl oligopeptide, palmitoyl tetrapeptide-7, rosa roxburghii fruit extract, coffea arabica (coffee) seed extract, vaccinium myrtillus fruit extract, hydroxyproline, fagus sylvatica bud extract, lecithin, behenyl alcohol, glycine soja (soybean) sterols, butyrospermum parkii (shea) butter, astrocaryum murumuru seed butter, tocopheryl acetate, linoleic acid, linum usitatissimum (linseed) seed oil, triolein, oleic acid, caprylic/capric triglyceride, argania spinosa kernel oil, palmitic acid, stearic acid, tocopherol, phytosteryl canola glycerides, glycyrrhetinic acid, cetyl alcohol, copernicia cerifera (carnauba) wax, lycium barbarum fruit extract, sorghum bicolor stalk juice, linum usitatissimum (linseed) seed extract, myrciaria dubia fruit extract, ascorbic acid, calcium pantothenate, magnesium gluconate, niacinamide, pyridoxine HCl, retinyl palmitate, cyanocobalamin, zinc picolinate, glyceryl caprylate, sodium polystyrene sulfonate, xanthan gum, acacia senegal gum, aluminum stearate, polyhydroxystearic acid, alumina, octyldodecyl neopentanoate, polyglyceryl-6 ricinoleate, isopropyl titanium triisostearate, HDI/trimethylol hexyllactone crosspolymer, silica, polyquaternium-7, menthoxypropanediol, carbomer, polysorbate 20, acrylamide/sodium acryloyldimethyltaurate copolymer, isohexadecane, polysorbate 80, sodium phytate, lactic acid, quaternium-90 bentonite, propylene carbonate, sorbitan tristearate, ethylhexylglycerin, phenoxyethanol, fragrance, citric acid, sodium hydroxide, mica, iron oxides.

Questions or Comments?

1-866-992-6722

Monday – Friday 9 AM – 5 PM PST

Dist. By BORBA, Inc., Woodland Hills, CA 91367.

PRINCIPAL DISPLAY PANEL - 21 mL Carton Label

NEW!

BORBA

PMS
SKIN RESCUE

7-DAY
TREATMENT SYSTEM

FOR WHEN SIGNS OF PMS
ERUPT ON YOUR SKIN

fresh doses of
powerful treatment to
use morning & night

A.M.
SPF 40+
treatment

P.M.
treatment

CLINICALLY TESTED
INSIDE-OUT SOLUTIONS

14 PIECE KIT
7 Ampoules – A.M. SPF 40+ Treatment
7 Ampoules – P.M. Treatment

0.05 fl oz. (1.5 mL) EACH ∙ TOTAL 0.7 fl oz (21 mL)

PRINCIPAL DISPLAY PANEL - 21 mL Carton Label

BORBA PMS SKIN RESCUE   A.M. SPF 40 PLUS TREATMENT
titanium dioxide and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59734-271
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 25 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 21 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
BUTYLENE GLYCOL  
ALKYL (C12-15) BENZOATE  
OCTYLDODECANOL  
DIMETHICONE 350  
GLYCERYL MONOSTEARATE  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE  
POLYSORBATE 60  
POVIDONE K90  
N-ACETYLGLUCOSAMINE  
COCOA BUTTER  
OATMEAL  
HYALURONATE SODIUM  
ALPINE STRAWBERRY  
ACAI  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)  
PALMITOYL OLIGOPEPTIDE  
PALMITOYL TETRAPEPTIDE-7  
ROSA MULTIFLORA FRUIT  
ARABICA COFFEE BEAN  
BILBERRY  
HYDROXYPROLINE  
FAGUS SYLVATICA FLOWER BUD  
LECITHIN, SOYBEAN  
DOCOSANOL  
SOY STEROL  
SHEA BUTTER  
ASTROCARYUM MURUMURU SEED BUTTER  
.ALPHA.-TOCOPHEROL ACETATE, D-  
LINOLEIC ACID  
LINSEED OIL  
TRIOLEIN  
OLEIC ACID  
MEDIUM-CHAIN TRIGLYCERIDES  
ARGAN OIL  
PALMITIC ACID  
STEARIC ACID  
ALPHA-TOCOPHEROL  
ENOXOLONE  
CETYL ALCOHOL  
CARNAUBA WAX  
LYCIUM BARBARUM FRUIT  
FLAX SEED  
MYRCIARIA DUBIA FRUIT  
ASCORBIC ACID  
CALCIUM PANTOTHENATE  
MAGNESIUM GLUCONATE  
NIACINAMIDE  
PYRIDOXINE HYDROCHLORIDE  
VITAMIN A PALMITATE  
CYANOCOBALAMIN  
ZINC PICOLINATE  
GLYCERYL CAPRYLATE  
SODIUM POLYSTYRENE SULFONATE  
XANTHAN GUM  
ACACIA  
ALUMINUM STEARATE  
POLYHYDROXYSTEARIC ACID (2300 MW)  
ALUMINUM OXIDE  
OCTYLDODECYL NEOPENTANOATE  
SILICON DIOXIDE  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)  
CARBOMER HOMOPOLYMER TYPE C  
POLYSORBATE 20  
ISOHEXADECANE  
POLYSORBATE 80  
LACTIC ACID  
BENTONITE  
PROPYLENE CARBONATE  
SORBITAN TRISTEARATE  
ETHYLHEXYLGLYCERIN  
PHENOXYETHANOL  
ANHYDROUS CITRIC ACID  
SODIUM HYDROXIDE  
MICA  
FERRIC OXIDE RED  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59734-271-30 7 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 1.5 mL in 1 TUBE This package is contained within the CARTON (59734-271-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 01/07/2011

Labeler - Borba, Inc. (605945042)

Revised: 04/2011 Borba, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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