01 MOISTURE FOUNDATION SPF 15- octinoxate and zinc oxide emulsion 02 MOISTURE FOUNDATION SPF 15- octinoxate and zinc oxide emulsion 03 MOISTURE FOUNDATION SPF 15- octinoxate and zinc oxide emulsion 04 MOISTURE FOUNDATION SPF 15- octinoxate and zinc oxide emulsion 05 MOISTURE FOUNDATION SPF 15- octinoxate and zinc oxide emulsion 06 MOISTURE FOUNDATION SPF 15- octinoxate and zinc oxide emulsion 07 MOISTURE FOUNDATION SPF 15- octinoxate and zinc oxide emulsion 08 MOISTURE FOUNDATION SPF 15- octinoxate and zinc oxide emulsion

08 Moisture Foundation SPF 15 by

Drug Labeling and Warnings

08 Moisture Foundation SPF 15 by is a Otc medication manufactured, distributed, or labeled by The Body Shop Wake Forest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Octinoxate (7.5%),: Sunscreen
• Zinc Oxide (7.80%).: Sunscreen

Uses

• helps prevent sunburn.
• higher SPF gives more protection.

Warning

• For external use only.

When using this product

• keep out of eyes.

Rinse with water to remove.

Stop and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children

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

Directions

• apply evenly before sun exposure and as needed.
• for use in children under 6 months old, ask a doctor.
• shake well before use.

Inactive Ingredients

Water, Cyclomethicone, Propylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Dextrin Palmitate, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Isopropyl Lanolate, Sclerocarya Birrea (Marula) Oil, Phenoxyethanol, Polyethylene, Sodium Chloride, Beeswax, Boron Nitride, Ethylene Brassylate, Glycerin, Tocopheryl Acetate, Methylparaben, PEG-40 Hydrogenated Castor Oil, Hectorite, Phenyl Methicone, Xanthan Gum, Propylparaben, Triethoxycaprylylsilane, Sodium Hyaluronate, Pyrus Malus (Apple) Extract, Ethylparaben, Butylparaben, Isobutylparaben, Titanium Dioxide, Iron Oxides.

SPL UNCLASSIFIED SECTION

© 2008 THE BODY SHOP INT'L PLC, BN17 6LS, UK.

MADE IN USA DIST:THE BODY SHOP WAKE FOREST,
NC 27587, USA; ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com

PRINCIPAL DISPLAY PANEL - 30 mL label

THE BODY SHOP®

MOISTURE FOUNDATION
SPF 15
FOND DE TEINT HYDRATANT
IND 15

30 mL
(1.0 US FL OZ)

PRINCIPAL DISPLAY PANEL - 01 bottle label

01 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821578
SKU: 83161

PRINCIPAL DISPLAY PANEL - 02 bottle label

02 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821579
SKU: 83107

PRINCIPAL DISPLAY PANEL - 03 bottle label

03 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821580
SKU: 83108

PRINCIPAL DISPLAY PANEL - 04 bottle label

04 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821581
SKU: 83109

PRINCIPAL DISPLAY PANEL - 05 bottle label

05 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821582
SKU: 83110

PRINCIPAL DISPLAY PANEL - 06 bottle label

06 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821583
SKU: 83112

PRINCIPAL DISPLAY PANEL - 07 bottle label

07 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821584
SKU: 83113

PRINCIPAL DISPLAY PANEL - 08 bottle label

08 moisture foundation SPF 15

ACTIVE INGREDIENTS: Octinoxate 7.5%,
Zinc Oxide 7.80%.

Reports of serious side effects associated
with use of product can be sent to:
THE BODY SHOP 5036 One World Way,
Wake Forest, NC 27587 USA.
© 2008 THE BODY SHOP INT'L PLC,
BN17 6LS, UK. ® registered trademark of
The Body Shop Int'l Plc. thebodyshop.com
MADE IN USA

PEEL FOR DRUG
INFORMATION AND
INGREDIENTS

821585
SKU: 83162

INGREDIENTS AND APPEARANCE

01 MOISTURE FOUNDATION SPF 15 
octinoxate and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mg  in 0.5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.9 mg  in 0.5 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-161-30	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/06/2009

02 MOISTURE FOUNDATION SPF 15 
octinoxate and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mg  in 0.5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.9 mg  in 0.5 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-107-30	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/06/2009

03 MOISTURE FOUNDATION SPF 15 
octinoxate and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mg  in 0.5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.9 mg  in 0.5 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-108-30	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/06/2009

04 MOISTURE FOUNDATION SPF 15 
octinoxate and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mg  in 0.5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.9 mg  in 0.5 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-109-30	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/06/2009

05 MOISTURE FOUNDATION SPF 15 
octinoxate and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mg  in 0.5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.9 mg  in 0.5 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-110-30	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/06/2009

06 MOISTURE FOUNDATION SPF 15 
octinoxate and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mg  in 0.5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.9 mg  in 0.5 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-112-30	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/06/2009

07 MOISTURE FOUNDATION SPF 15 
octinoxate and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mg  in 0.5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.9 mg  in 0.5 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-113-30	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/06/2009

08 MOISTURE FOUNDATION SPF 15 
octinoxate and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.75 mg  in 0.5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.9 mg  in 0.5 mL

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-162-30	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/06/2009

Labeler - The Body Shop Wake Forest (791071279)