ORANGE VANILLA SPF30- zinc oxide stick 
Crossing Cultures LLC dba Goddess Garden

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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Goddess Garden SPF30 Orange Vanilla Lip Balm

Drug Facts

Active Ingredient

Zinc Oxide 5.7%

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. If swallowed, get medical help or contact a Poison Control Center right away.

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 and remove.

Keep out of reach of children

If swallowed, get medical help or contact Poison 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.

* Children under 6 months of age: Ask a doctor.

* 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 sun, especially from 10a.m. to 2p.m.

- Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

* Protect this product from excessive heat and direct sun.

* Store at temperatures below 90'F.

* May Stain some fabrics or surfaces.

Inactive Ingredients

Bisabolol*, Butyrospermum Parkii (Shea Butter)*, Caprylic/Capric Triglyceride (Coconut Oil), Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Euphorbia Cerifera (Candelilla) Wax, Flavor (Natural Vanilla Flavor), Jojoba Esters, Olea Europaea (Olive) Fruit Oil*, Oryzanol, Schinziophyton Rautanenii (Mongongo) Kernel Oil*, Stevia Rebaudiana Extract, Theobroma Cacao (Cocoa) Seed Butter*, Theobroma Grandiflorum (Cupuassu) Seed Butter, Tocopherol (Vitamin E)

*Certified Organic

Questions or Comments

Toll-free 1-855-SAFE-SUN or www.GoddessGarden.com

Dist. by: Goddess Garden, Boulder, CO 80301 ©2017

Product Label

Orange Vanilla

ORANGE VANILLA  SPF30
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-074
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL (UNII: 6UYK2W1W1E)  
COCOA BUTTER (UNII: 512OYT1CRR)  
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
GAMMA ORYZANOL (UNII: SST9XCL51M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
ORANGE OIL (UNII: AKN3KSD11B)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
LEVOMENOL (UNII: 24WE03BX2T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58479-074-044 g in 1 TUBE; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2017
Labeler - Crossing Cultures LLC dba Goddess Garden (078444606)
Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)

Revised: 4/2018
Document Id: 6a2177c6-4096-739a-e053-2a91aa0ad97a
Set id: 6a2177c6-4095-739a-e053-2a91aa0ad97a
Version: 1
Effective Time: 20180418
 
Crossing Cultures LLC dba Goddess Garden