Label: GADIS LIP MOISTURIZER SPF15- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 69065-001-02, 69065-001-04 - Packager: Gadis Ingenious Gadgets Inc.
- 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 September 9, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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Directions
- apply liberally and evenly 15 minutes before sun exposure.
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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:
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Limit time in the sun, especially from
10 a.m. – 2 p.m.
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Wear long-sleeved shirts, pants, hats
and sunglasses
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Reapply:
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After 40 minutes swimming or
sweating
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Immediately after towel drying
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At least every 2 hours
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Children under 6 months of age: Ask
a doctor
- Other information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Gadis Lip Moisturizer SPF 15
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INGREDIENTS AND APPEARANCE
GADIS LIP MOISTURIZER SPF15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69065-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 3 g in 100 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) CANDELILLA WAX (UNII: WL0328HX19) 2-BUTYLOCTYL METHACRYLATE (UNII: C927XK2YP0) SHEANUT OIL (UNII: O88E196QRF) MACADAMIA OIL (UNII: 515610SU8C) CARNAUBA WAX (UNII: R12CBM0EIZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69065-001-02 1.4 g in 1 CARTON 2 NDC:69065-001-04 2.8 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 08/06/2014 Labeler - Gadis Ingenious Gadgets Inc. (037630799)
