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NDC 69842-0083-01 Sport Sunstick SPF 30 Sunscreen 20; 75; 30 mg/g; mg/g; mg/g Details

Sport Sunstick SPF 30 Sunscreen 20; 75; 30 mg/g; mg/g; mg/g

Sport Sunstick SPF 30 Sunscreen is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is AVOBENZONE; OCTINOXATE; OCTISALATE.

Product Information

NDC	69842-0083
Product ID	69842-083_51e197be-8f55-40e7-ba69-f81ba388c08e
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	Sport Sunstick SPF 30 Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	avobenzone, octinoxate, octisalate
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	20; 75; 30
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; OCTINOXATE; OCTISALATE
Labeler Name	CVS Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0083-01 (69842008301)

Pricing Information	N/A
NDC Package Code	69842-083-01
Billing NDC	69842008301
Package	1 CASE in 1 BLISTER PACK (69842-083-01) / 7 g in 1 CASE
Marketing Start Date	2017-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2dda092d-cc09-468c-a805-7a7f78827d44 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 2.0%

Octinoxate 7.5%

Octisalate 3.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only.

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Directions

Apply liberally 15 minutes before sun exposure
children under the age of 6: Ask a doctor
reapply at least every 2 hours
reapply after 80 minutes of swimming or sweating and immediately after towel drying

Other information

Protect the product in this container from excessive heat and direct sunlight.

Inactive ingredients

Cera Alba, Ricinus Communis, Hydrogenated Olive Oil Decyl Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Copernicia Cerifera, Fragrance, Persea Gratissima, Limnanthes Alba (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Citrus Limon (Lemon) Peel Oil, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Tetraisopalmitate, Ascorbyl Palmitate, Ammonium Glycyrrhizate, BHT, Phenoxyethanol

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2017 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components

FP127 M050976 V-32991

CVS® Quality

Money Back Guarantee

Principal Display Panel - Sport Sunstick Blister Pack Label

CVS Health™

SPORT

SUNSTICK

SPF 30 SUNSCREEN

Lip & face protection

With avocado oil & jojoba oil
Water resistant (80 minutes)
Paraben free & dermatologist tested

NET WT

0.25 OZ

(7 g)

Principal Display Panel - Sport Sunstick Blister Pack Label

Principal Display Panel - Sport Sunstick Label

CVS Health™

SPORT

SUNSTICK

SPF 30 SUNSCREEN

Lip & face protection

With avocado oil & jojoba oil
Water resistant (80 minutes)

NET WT 0.25 OZ (7 g)

Principal Display Panel - Sport Sunstick Label

INGREDIENTS AND APPEARANCE

SPORT SUNSTICK SPF 30 SUNSCREEN

avobenzone, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-083
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	20 mg in 1 g
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	75 mg in 1 g
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
HYDROGENATED OLIVE OIL DECYL ESTERS (UNII: XQ691JJ99N)
JOJOBA OIL (UNII: 724GKU717M)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CARNAUBA WAX (UNII: R12CBM0EIZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
LEMON OIL (UNII: I9GRO824LL)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-083-01	1 in 1 BLISTER PACK	04/01/2017
1		7 g in 1 CASE; 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	04/01/2017

Labeler - CVS Health (062312574)

Registrant - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)

Name	Address	ID/FEI	Business Operations
Establishment
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(69842-083) , PACK(69842-083) , LABEL(69842-083) , ANALYSIS(69842-083)

Revised: 4/2017

Document Id: 51e197be-8f55-40e7-ba69-f81ba388c08e

Set id: 2dda092d-cc09-468c-a805-7a7f78827d44

Version: 1

Effective Time: 20170417