NDC | 69065-001-02, 69065-001-04 |
Set ID | 02f768aa-9369-49c8-9a68-6fb7b85b6b18 |
Category | HUMAN OTC DRUG LABEL |
Packager | Gadis Ingenious Gadgets Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
-
Directions
- apply liberally and evenly 15 minutes before sun exposure.
-
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:
-
Limit time in the sun, especially from
10 a.m. – 2 p.m.
-
Wear long-sleeved shirts, pants, hats
and sunglasses
-
Reapply:
-
After 40 minutes swimming or
sweating
-
Immediately after towel drying
-
At least every 2 hours
-
Children under 6 months of age: Ask
a doctor
- Other information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Gadis Lip Moisturizer SPF 15
-
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)