NDC | 71496-0003-1 |
Set ID | 5326ae14-eb97-1351-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | ARI&J Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
apply generously 15 minutes before sun sxposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every two hours
Sun Protection Measures. Spending thime 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, expecially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months of age: Ask a doctor
-
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 swallowed, get medical help or contact a Poison Control Center right away.
- do not place this product in this container in the excessive heat and direct sun.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WATERFUL SUN
ethylhexyl methoxycinnamate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71496-0003 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 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71496-0003-1 50 mL in 1 TUBE; Type 0: Not a Combination Product 06/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/30/2017 Labeler - ARI&J Inc (694174441) Registrant - ARI&J Inc (694174441) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71496-0003) Establishment Name Address ID/FEI Business Operations ARI&J Inc 694174441 label(71496-0003) , pack(71496-0003)