GODDESS GARDEN ORGANICS GRAPEFRUIT BERGAMOT DAILY BROAD SPECTRUM SPF 15- titanium dioxide, zinc oxide lotion
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 ORGANICS Grapefruit Bergamot DAILY LOTION BROAD SPECTRUM SPF 15

Active Ingredients

Titanium Dioxide 3.7% Zinc Oxide 3%

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 Center right away.

Directios

Apply liberally 15 minutes before sun exposure.
Reapply:
After 40 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 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.

Inactive Ingredients

Aloe Vera*, Butyrospermum Parkii (Shea Butter) Seed Oil*, Cetyl Alcohol, Citrus Bergamia (Bergamot) Essential Oil, Citrus Paradisi Peel (Grapefruit) Essential Oil, Gluconolactone, Glycerin*, Glyceryl Stearate, Glycine Soja (Soybean) Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Ionicera Caprifoium (Honeysuckle) Extract, Ionicera Japonica (Honeysuckle) Flower Extract, Polyhydroxystearic Acid, Populus Tremuloicles (Aspen) Bark Extract, Radish Root Ferment Filtrate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum.
*Certified Organic

Other information

Protect this product from excessive heat and direct sun.

Questions or Comments

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

GODDESS GARDEN ORGANICS Grapefruit Bergamot DAILY LOTION BROAD SPECTRUM SPF 15 236ml (58479-000-00)

Label

GODDESS GARDEN ORGANICS GRAPEFRUIT BERGAMOT DAILY BROAD SPECTRUM SPF 15
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58479-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	37 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEANUT OIL (UNII: O88E196QRF)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58479-000-00	1 in 1 CARTON	05/24/2013	06/01/2016
1		236 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/24/2013	06/01/2016

Labeler - Crossing Cultures, LLC dba Goddess Garden (078444606)

Name	Address	ID/FEI	Business Operations
Establishment
Crossing Cultures, LLC dba Goddess Garden		078444606	manufacture(58479-000)

Revised: 12/2016

Document Id: 432e6e23-6371-3bf7-e054-00144ff8d46c

Set id: 6b97941c-35de-42bc-93d0-18167bb224e3

Version: 2

Effective Time: 20161208

Crossing Cultures, LLC dba Goddess Garden