KARI GRAN ESSENTIAL SPF SPF 28- zinc oxide lotion

KARI GRAN ESSENTIAL SPF by

Drug Labeling and Warnings

KARI GRAN ESSENTIAL SPF by is a Otc medication manufactured, distributed, or labeled by GRAN KARI INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

NON-NANO ZINC OXIDE

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN
• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

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

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, SEEK MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• SHAKE WELL. APPLY AT LEAST 1 PUMP TO FACE. APPLY ADDITIONAL PUMPS TO NECK AND CHEST - AREAS THAT ARE OFTEN IGNORED.
• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
• REAPPLY 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
•       LIMIT TIME IN THE SUN, ESPECIALLY BETWEEN 10 A.M. AND 2 P.M.
•       WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES
• CHILDREN UNDER 6 MONTHS: CONSULT A PHYSICIAN

INACTIVE INGREDIENTS

NON-GMO RUBUS IDEAUS (RED RASPBERRY SEED) OIL, NON-GMO PRUNUS DOMESTICA (FRENCH PLUM SEED) OIL, ORGANIC MACADAMIA TERNIFOLIA (MACADAMIA NUT SEED) OIL, NON-GMO ALEURITES MOLUCCANA (KUKUI SEED) OIL, ORGANIC PERSEA GRATISSIMA (AVOCADO) OIL, ORGANIC SIMMONDSIA CHINENSIS (JOJOBA SEED) OIL, ORGANIC BEESWAX, TOCOPHEROL (NON-GMO VITAMIN E FROM SUNFLOWER).

STORAGE AND HANDLING

KEEP THIS PRODUCT AWAY FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT

QUESTIONS OR COMMENTS?

CALL MONDAY THROUGH FRIDAY, 206-588-1573 (9 A.M. TO 5 P.M. PST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KARI GRAN ESSENTIAL SPF  SPF 28
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73665-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	17 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
RASPBERRY SEED OIL (UNII: 9S8867952A)
PLUM SEED OIL (UNII: 67EIU8N086)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73665-101-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020
2	NDC: 73665-101-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020
3	NDC: 73665-101-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/29/2020

Labeler - GRAN KARI INC (028492351)

Establishment
Name	Address	ID/FEI	Business Operations
GRAN KARI INC		028492351	manufacture(73665-101)