SPORT MINERAL SUN- zinc oxide stick

SPORT MINERAL SUN by

Drug Labeling and Warnings

SPORT MINERAL SUN by is a Otc medication manufactured, distributed, or labeled by Synchronicity Spa, Inc. DBA Suntegrity. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide (20%)

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

• Stop use and ask a doctor if rash occurs

• When using this product keep out of eyes. Rinse with water to remove.

• 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
• 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 skin early 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 10am to 2pm
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months; Ask a doctor

Inactive Ingredients

cocos nucifera (coconut) oil1, helianthus annuus (sunflower) seed oil1, cera alba (beeswax)1, euphorbia cerifera (candelilla wax), copernicia cerifera (carnauba) wax1, butyrospermum parkii (shea) butter1, ricinus communis (castor) seed oil1, tocopherol, theobroma cacao (cocoa) seed butter1, aloe barbadensis leaf juice (aloe vera)1, citrus sinensis (sweet orange) essential oil1, hibiscus flavor oil

1 certified organic ingredient

Other Information

• protect this product from excessive heat & direct sun

SPL UNCLASSIFIED SECTION

Distributed By
Suntegrity Skincare®
Las Vegas, NV 89128

PRINCIPAL DISPLAY PANEL - 46 g Cylinder Label

sun
tegrity®

MINERAL
SUN STICK

SPORT

Water Resistant
(80 Minutes)

BROAD SPECTRUM
SPF 30

Reef Friendly
& Cruelty Free
NSF
contains organic
ingredientsCM

NET WT 1.62 OZ (46g)

INGREDIENTS AND APPEARANCE

SPORT MINERAL SUN 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69949-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WHITE WAX (UNII: 7G1J5DA97F)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
CASTOR OIL (UNII: D5340Y2I9G)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69949-201-01	22 g in 1 CYLINDER; Type 0: Not a Combination Product	08/01/2018
2	NDC: 69949-201-02	46 g in 1 CYLINDER; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2018

Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)