Label: ALL NATURAL- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76105-714-01, 76105-714-02, 76105-714-03, 76105-714-04 - 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 22, 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 22%..........prevention of sunburn
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.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.Capric/Caprylic Triglyceride, Vitis Vinifera (Grape) Seed Oil, Silicon
Dioxide, Cera Alba (Beeswax), Butyrospermum Parkii
Seed (Shea) Butter, Euphorbia Antisyphilitica (Candelilla)
Wax, Polyhydroxystearic Acid, Simmondsia Chinensis
(Jojoba), Cucumis Sativus (Cucumber) Seed
Extract*, Persea Gratissima (Avocado), Rosa Canina
(Rosehips) Seed Oil*, Carota Sativa (Carrot) Oil, Botswellia
Carterii (Frankincense), Camellia Sinensis (Green
Tea) Extract*. *Certified Organic
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALL NATURAL SUNCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76105-714 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 22.5 g in 100 g Inactive Ingredients Ingredient Name Strength GRAPE SEED OIL (UNII: 930MLC8XGG) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SHEA BUTTER (UNII: K49155WL9Y) CANDELILLA WAX (UNII: WL0328HX19) JOJOBA OIL (UNII: 724GKU717M) CUCUMBER SEED (UNII: BT3S9L53JK) AVOCADO (UNII: SDS87L369F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76105-714-02 1 in 1 BOX 1 NDC:76105-714-01 5.3 g in 1 TUBE 2 NDC:76105-714-04 1 in 1 BOX 2 NDC:76105-714-03 3.5 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
