Label: SPF 30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76105-525-01, 76105-525-02 - Packager: Eco Skin Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 24, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredient.................Purpose
Zinc Oxide 20%.........prevention of sunburnWhen 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.Apply smoothly and evenly to
exposed areas 20 minutes before sun exposure.
Repeat as necessary and after towel drying,
swimming or sweating. For adults and children
of all ages. For children under 6 months
consult a doctor
Purified Water (Aqua),
Isoamyl Laurate, Capric/Caprylic Triglyceride,
Sorbitan Stearate, Sucrose Cocoate, Caprylyl
Glycol, Cetearyl Alcohol, Cetearyl Glucoside,
Hydroxypropyl Starch Phosphate, Polyhydroxystearic
Acid, Xanthan Gum, Cucumis Sativus
(Cucumber) Seed Extract*, Rosa Canina
(Rosehips) Seed Oil*, Camellia Sinensis (Green
Tea) Extract*. *Certified Organic
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 30 FACE
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76105-525 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 20 g in 100 g Inactive Ingredients Ingredient Name Strength ISOAMYL LAURATE (UNII: M1SLX00M3M) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SUCROSE COCOATE (UNII: 3H18P0UK73) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) XANTHAN GUM (UNII: TTV12P4NEE) CUCUMBER SEED (UNII: BT3S9L53JK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76105-525-02 1 in 1 BOX 1 NDC:76105-525-01 1.8 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/22/2011 Labeler - Eco Skin Care (966826914) Registrant - Eco Skin Care (966826914) Establishment Name Address ID/FEI Business Operations Baxter Laboratories Pty. Ltd. 740537709 manufacture
