Label: THEFACESHOP JELLY PACT 34200188- octinoxate, titanium dioxide and zinc oxide gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-188-37 - Packager: THEFACESHOP CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 20, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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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 product is swallowed, get medical help or contact a Poison Control Center right away.
Close the cover to prevent the moisturizing ingredients from evaporating.
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Directions
Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
Apply to all skin exposed to the sun.
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
Apply an adequate amount on face in a light patting motion by using puff. - Other Information
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Inactive Ingredients
Mica (CI 77019), Caprylic/Capric Triglyceride, Polymethyl Methacrylate, Dimethicone, Talc, Methyl Methacrylate Crosspolymer, Diisostearyl Malate, Dimethicone/Vinyl Dimethicone Crosspolymer, Pentylene Glycol, Methicone, Lauroyl Lysine, Aluminum Hydroxide, Silica, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxyapatite, Argania Spinosa Kernel Oil, Persea Gratissima (Avocado) Oil, Olea Europaea (Olive) Fruit Oil, Lilium Candidum Bulb Extract, Fragrance(Parfum), Iron Oxides (CI 77491, CI 77492, CI 77499)
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INGREDIENTS AND APPEARANCE
THEFACESHOP JELLY PACT 34200188
octinoxate, titanium dioxide and zinc oxide gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-188 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE .6 g in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE .17 g in 10 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE .29 g in 10 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-188-37 1 in 1 CARTON 11/20/2014 1 10 g in 1 CONTAINER; 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 11/20/2014 Labeler - THEFACESHOP CO., LTD. (688329416) Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193) Establishment Name Address ID/FEI Business Operations THEFACESHOP Co., Ltd. 688329416 label(51523-188)
