THE ORGANIC PHARMACY CELLULAR PROTECTION SUNSCREEN SPF 30- titanium dioxide and zinc oxide cream 
THE ORGANIC PHARMACY CELLULAR PROTECTION SUNSCREEN SPF 50- titanium dioxide and zinc oxide cream 
The organic pharmacy Limited

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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The Organic Pharmacy-Cellular Protection Sunscreen SPF 30 & SPF 50

Carton.DrugFactsSPF50

Active ingredients

Zinc Oxide 12.5%

Titanium Dioxide 1%

Uses

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

Directions

Inactive ingredients

Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Alcohol, Aqua, Glycerin, Behenyl Alcohol, Cetearyl Alcohol, Glyceryl Stearate, Butyrospermum Parkii Butter, Calendula Officinalis Extract, Helianthus Annuus Seed Oil, Rosa Canina Fruit Oil, Phospholipids, Parfum , Xanthan Gum, Citrus Grandis Seed Extract, Lactic Acid, Glycine Soja Sterols, Silica, Tocopherol

Other information

Questions or comments?

UK-0844-800-8399

US-310-272-7275

DrugFactsSPF50

Carton.PrincipalDisplayPanelSPF50

Cellular Protection Sunscreen

High Protection UVA & UVB

Broad spectrum SPF 50

SPF50

Protect & Hydrate

With Marigold, Rose Hip & Shea Butter

PrincipalDisplayPanelSPF50

CartonSPF30.DrugFacts

Active ingredients

Zinc Oxide 10 %

Titanium Dioxide 1%

Uses

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

Directions

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aqua, Caprylic/Capric Triglyceride, Alcohol, Glycerin, Behenyl Alcohol, Cetearyl Alcohol, Glyceryl Stearate, Butyrospermum Parkii Butter, Calendula Officinalis Extract, Helianthus Annuus Seed Oil, Rosa Canina Fruit Oil, Phospholipids, Parfum , Xanthan Gum, Citrus Grandis Seed Extract, Lactic Acid, Glycine Soja Sterols, Silica, Tocopherol

Other information

Questions or comments?

UK-0844-800-8399

US-310-272-7275

DrugFacts

Carton.PrincipalDisplayPanelSPF30

Cellular Protection Sunscreen

High Protection UVA & UVB

Broad spectrum SPF 30

SPF30

Protect & Hydrate

With Marigold, Rose Hip & Shea Butter

PrincipalDisplayPanelSPF30

THE ORGANIC PHARMACY CELLULAR PROTECTION SUNSCREEN SPF 30 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69303-630
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.0000 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.0000 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 40.0000 g  in 100 g
WATER (UNII: 059QF0KO0R) 12.7760 g  in 100 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 10.0000 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) 10.0000 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 5.0760 g  in 100 g
DOCOSANOL (UNII: 9G1OE216XY) 2.1150 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2.0000 g  in 100 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 1.5750 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y) 1.0000 g  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 1.0000 g  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI) 1.0000 g  in 100 g
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) 1.0000 g  in 100 g
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) 0.6750 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 0.2000 g  in 100 g
LACTIC ACID (UNII: 33X04XA5AT) 0.1800 g  in 100 g
SOY STEROL (UNII: PL360EPO9J) 0.1350 g  in 100 g
CITRUS MAXIMA SEED (UNII: 083X55C543) 0.1180 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.1000 g  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8) 0.0500 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69303-630-011 in 1 CARTON07/15/2014
1150 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/15/2014
THE ORGANIC PHARMACY CELLULAR PROTECTION SUNSCREEN SPF 50 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69303-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.0000 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.5000 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 40.0000 g  in 100 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 12.5000 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) 10.0000 g  in 100 g
WATER (UNII: 059QF0KO0R) 7.7760 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 5.0760 g  in 100 g
DOCOSANOL (UNII: 9G1OE216XY) 2.1150 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2.0000 g  in 100 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 1.5750 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y) 1.0000 g  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 1.0000 g  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI) 1.0000 g  in 100 g
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) 1.0000 g  in 100 g
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) 0.6750 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 0.2000 g  in 100 g
LACTIC ACID (UNII: 33X04XA5AT) 0.1800 g  in 100 g
SOY STEROL (UNII: PL360EPO9J) 0.1350 g  in 100 g
CITRUS MAXIMA SEED (UNII: 083X55C543) 0.1180 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.1000 g  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8) 0.0500 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69303-650-011 in 1 CARTON07/15/2014
1150 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/15/2014
Labeler - The organic pharmacy Limited (220198688)
Registrant - The organic pharmacy Limited (220198688)
Establishment
NameAddressID/FEIBusiness Operations
The Organic Pharmacy Limited220198688manufacture(69303-630, 69303-650)

Revised: 7/2018
Document Id: 97fe3f34-c970-41c9-bbaf-b32ce297da81
Set id: bef7f054-fa35-453a-8395-da879409db6e
Version: 15
Effective Time: 20180717
 
The organic pharmacy Limited