KIDS MINERAL SUNSCREEN ROLL-ON SPF-50- zinc oxide lotion

KIDS MINERAL SUNSCREEN ROLL-ON by

Drug Labeling and Warnings

KIDS MINERAL SUNSCREEN ROLL-ON by is a Otc medication manufactured, distributed, or labeled by PROJECT SUNSCREEN, HealthSpecialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ZINC OXIDE 18%

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 PRODUCTS IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• SHAKE WELL BEFORE USE
• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
• REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING
• IMMEDIATELY AFTER TOWEL DRYING
• 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 10AM-2PM
• WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
• CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

OTHER INFORMATION

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENTS

Water (Aqua), Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Glycerin, Coconut Alkanes, Coco-Caprylate/Caprate, Bis-Stearyl Dimethicone, Cetearyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Galactoarabinan, Niacinamide, Capryloyl Glycerin/Sebacic Acid Copolymer, Polyhydroxystearic Acid, Tocopheryl Acetate, Physalis Angulata Extract, Caprylic/Capric Triglycerides, 1,2-Hexanediol, Propanediol, Caprylhydroxamic Acid

QUESTIONS?

CALL 424.262.9462 OR VISIT PROJECTSUNSCREEN.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS MINERAL SUNSCREEN ROLL-ON  SPF-50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72688-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GALACTOARABINAN (UNII: SL4SX1O487)
NIACINAMIDE (UNII: 25X51I8RD4)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72688-104-11	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	03/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/04/2019

Labeler - PROJECT SUNSCREEN (080823314)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC.		021072509	manufacture(72688-104)