CAPE COD SUNSCREEN PLUS SPF 30- titanium dioxide, zinc oxide lotion

Cape Cod Sunscreen Plus SPF 30 by

Drug Labeling and Warnings

Cape Cod Sunscreen Plus SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cape Cod All Natural, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Titanium Dioxide 6.00%, Zinc Oxide 6.00%

Sunburn Protection

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions: 

• Apply liberally 15-minutes before sun exposure.
• Reapply: At least, every two-hours. Immediately after swimming, sweating or towel drying.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Limit time in the sun, especially between 10am and 2pm.  Wear long sleeve shirts, pants, hats and sunglasses.  For children under 6-months, consult a physician.

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 consult physician if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Other Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Leaf Extract, Cymbopogon Citratus (Lemongrass) Oil, Daucus Carota Sativa (Carrot) Extract, Ethylhexyl Palmitate, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glycine Soja (Soybean)
Oil. Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Phenoxythanol, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Lauryglucosides, Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Product Label

INGREDIENTS AND APPEARANCE

CAPE COD SUNSCREEN PLUS SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69673-635
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
CARROT (UNII: L56Z1JK48B)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SESAME OIL (UNII: QX10HYY4QV)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69673-635-00	1 in 1 CARTON	02/09/2017
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/14/2015

Labeler - Cape Cod All Natural, Inc. (068334921)