GREEN SCREEN SPF 31 PEACH SUNSCREEN- zinc oxide cream 
Kabana Skin Care LLC

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 Ingredients

Zinc Oxide** USP 25%

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 if used as directed with other sun protection measures

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 product is swallowed, get medical help or contact a Poison Control Center right away

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply:
  • after 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 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-sleeve shirts, pants, hats, and sunglasses

  • children under 6 months: Ask a Doctor

Inactive Ingredients

Eldorado Springs Artesian Water (aqua), extra virgin olive oil* (Oleo europaea fruit oil), jojoba oil* (Simmondsia chinensis oil), vegetable glycerin# (glycerin), shea butter* (Butyrospermum parkii seed oil), vegetable emulsifying wax NF # (cetearyl alcohol and polysorbate 60), vegetable vitamin e # (tocopherol), iron oxide (iron oxides)

*Certified Organic by USDA/NOP **non-nano, uncoated, French Process zinc oxide #Non-GMO

Other Information

  • protect this product from excessive heat and direct sun

Questions or comments?

Call Kabana Skin Care toll free at 1-888-517-0414 or visit www.kabanaskincare.com

Drug Facts

Green Screen SPF 31 Peach Sunscreen Package Insert

GREEN SCREEN SPF 31 PEACH SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73369-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 1.38 g  in 100 g
JOJOBA OIL (UNII: 724GKU717M) 3.75 g  in 100 g
WATER (UNII: 059QF0KO0R) 35 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) 0.15 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M) 1.125 g  in 100 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.85 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.125 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y) 1.93 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E) 25.95 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 3.75 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73369-0003-1115 g in 1 TUBE; Type 0: Not a Combination Product01/11/2013
2NDC:73369-0003-230 g in 1 TUBE; Type 0: Not a Combination Product01/11/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/11/2013
Labeler - Kabana Skin Care LLC (080237112)
Registrant - Kabana Skin Care LLC (080237112)
Establishment
NameAddressID/FEIBusiness Operations
Kabana Skin Care LLC080237112manufacture(73369-0003)

Revised: 11/2021
Document Id: cffafe4b-0412-18c6-e053-2a95a90a6389
Set id: 969f4a3f-3460-2951-e053-2a95a90a0db1
Version: 3
Effective Time: 20211104
 
Kabana Skin Care LLC