![UNCOMPLIKATED MAKEUP SETTING SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [KATE SOMERVILLE SKINCARE LLC]](https://medic.hrt.org//dailymed/images/1a33cb41-440a-41cb-9832-24255bfa2b7c/UncompliKated_label_021417_v3OL.jpg)
| NDC | 43479-208-41 |
| Set ID | 1a33cb41-440a-41cb-9832-24255bfa2b7c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | KATE SOMERVILLE SKINCARE LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
- SHAKE WELL PRIOR TO USE.
- AVOID SPRAYING ON OR AROUND EYE AREA. CLOSE MOUTH.
- HOLD CAN 8-10" FROM FACE AND SPRAY IN A CLOCKWISE DIRECTION.
- DO NOT APPLY IN WINDY CONDITIONS.
- USE IN A WELL-VENTILATED AREA.
- APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
- USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
- REAPPLY AT LEAST EVERY 2 HOURS.
- 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.
- CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNCOMPLIKATED MAKEUP SETTING SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43479-208 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ISOBUTANE (UNII: BXR49TP611) PROPANE (UNII: T75W9911L6) ISODODECANE (UNII: A8289P68Y2) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) HYALURONIC ACID (UNII: S270N0TRQY) RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN) WATER (UNII: 059QF0KO0R) LAVENDER OIL (UNII: ZBP1YXW0H8) SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S) PENTYLENE GLYCOL (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43479-208-41 96 g in 1 CAN; Type 0: Not a Combination Product 11/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/18/2018 Labeler - KATE SOMERVILLE SKINCARE LLC (615155533) Establishment Name Address ID/FEI Business Operations Piedmont LLC 078482780 manufacture(43479-208)
