ACTIVE INGREDIENT

ZINC OXIDE 30%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

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.

DIRECTIONS

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
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.

OTHER INFORMATION

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

Caprylic/Capric Triglyceride, Beeswax, Montmorillonite, Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Theobroma Cacao (Cocoa) Powder, Tocopherol, Triethoxycaprylylsilane, Iron Oxides.

PDP

Base

KELSEN - UNDER THE SUN BROAD SPECTRUM SPF 50 MINERAL SUNSCREEN
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82626-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
YELLOW WAX (UNII: 2ZA36H0S2V)
MONTMORILLONITE (UNII: A585MN1H2L)
LANOLIN (UNII: 7EV65EAW6H)
COCOA BUTTER (UNII: 512OYT1CRR)
COCOA (UNII: D9108TZ9KG)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82626-102-11	50 g in 1 JAR; Type 0: Not a Combination Product	12/05/2022
2	NDC:82626-102-12	15 g in 1 JAR; Type 0: Not a Combination Product	12/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	12/05/2022

Labeler - KELSEN PRODUCTS INC (085656269)