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NDC 69673-0635-00 Cape Cod Sunscreen Plus SPF 30 60; 60 mg/mL; mg/mL Details

Cape Cod Sunscreen Plus SPF 30 60; 60 mg/mL; mg/mL

Cape Cod Sunscreen Plus SPF 30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cape Cod All Natural, Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	69673-0635
Product ID	69673-635_482d946f-62a7-0db3-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cape Cod Sunscreen Plus SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	TITANIUM DIOXIDE, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	60; 60
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Cape Cod All Natural, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 69673-0635-00 (69673063500)

Pricing Information	N/A
NDC Package Code	69673-635-00
Billing NDC	69673063500
Package	1 BOTTLE, PLASTIC in 1 CARTON (69673-635-00) / 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2017-02-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3e625a74-2c02-4cbc-b7ad-0b963f9fbe28 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/14/2015

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

Revised: 2/2017

Document Id: 482d946f-62a7-0db3-e054-00144ff8d46c

Set id: 3e625a74-2c02-4cbc-b7ad-0b963f9fbe28

Version: 3

Effective Time: 20170210