SUN GOO MINERAL SUN STICK- zinc oxide stick 
Sun Goo Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient (s)

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 doctor if rash occurs
Keep out of reach of children. If a product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly 15 minutes before sun exposure
Children under 6 months of age ask a doctor
Sun protection measures reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every two hours, spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10:00 a.m. – 2:00 p.m. wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Olive oil, beeswax, jojoba seed oil, cocoa seed butter, rosemary leaf extract, shea butter

Other information

Protect the product in this container from excessive heat and direct sun. Do not use if the seal is broken

Product label

image description

SUN GOO MINERAL SUN STICK 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82395-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL (UNII: 6UYK2W1W1E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
JOJOBA OIL (UNII: 724GKU717M)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SHEA BUTTER (UNII: K49155WL9Y)  
ROSEMARY (UNII: IJ67X351P9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82395-001-011 in 1 CARTON11/18/2021
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/18/2021
Labeler - Sun Goo Inc (118399952)

Revised: 11/2022
Document Id: eeb4a370-9b58-5565-e053-2a95a90a93f9
Set id: 4ac2f15b-0ba7-434d-9e5d-f6d0f2a7e7db
Version: 3
Effective Time: 20221130
 
Sun Goo Inc