Ginger Armor Mineral SPF 50

Ginger Armor Mineral SPF 50 by

Drug Labeling and Warnings

Ginger Armor Mineral SPF 50 by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GINGER ARMOR MINERAL SPF 50- titanium dioxide, zinc oxide lotion 
Spa de Soleil

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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Ginger Armor Mineral SPF 50

Active Ingredients

Titanium Dioxide 7.8%

Zinc Oxide 9.0%

Purpose

Sunscreen

Warnings

Warnings When using this product

• keep out of the eye area
• rinse with water to remove
• stop use and ask a doctor if rash or irritation develops
• for external use onlyl
• keep out of reach of children

Directions

Directions

Apply thin layer over clean face and body as needed
Reapply after swimming
Massage well
Allow complete penetration

Inactive Ingredients

Carthamus Tinctorius (Safflower) Seed Oil, Coconut

Alkanes, Coco Caprylate/Caprate, Caprylic/Capric Triglyceride,

Stearic Acid, Alumina, Polyhydroxystearic Acid, Helianthus

Annuus (Sunflower) Seed Oil, Pongamia Glabra Seed (Karanja)

Oil, Vitis Vinifera (Grape) Seed Oil, Olea Europaea (Olive) Oil,

Argania Spinsosa (Argan) Oil, Oryza Sativa (Rice) Bran Extract,

Rosmarinus Officinalis (Rosemary) Extract, Tocopherol, Argania

Spinosa Kernel Oil, Tocopheryl Acetate (Vitamin E), Bisabolol,

*Squalane * From Sugarcane

Principal Display Panel

GINGER ARMOR MINERAL SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-7300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.8 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE (UNII: J4BY50FL78)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-7300-1	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/29/2020	12/23/2022

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-7300)

Revised: 12/2022

Document Id: f0849d9e-9d47-5ed2-e053-2a95a90a25c4

34390-5

Set id: b2dc5605-9389-594c-e053-2995a90a3eed

Version: 3

Effective Time: 20221223