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NDC 69842-0552-02 CVS Health Original SPF 15 Lip Balm 7.5; 3.5; 44 mg/g; mg/g; mg/g Details

CVS Health Original SPF 15 Lip Balm 7.5; 3.5; 44 mg/g; mg/g; mg/g

CVS Health Original SPF 15 Lip Balm is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by CVS. The primary component is OCTINOXATE; OXYBENZONE; PETROLATUM.

Product Information

NDC	69842-0552
Product ID	69842-552_e49680bd-bd61-40cf-abc8-51a1c8808726
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	CVS Health Original SPF 15 Lip Balm
Proprietary Name Suffix	n/a
Non-Proprietary Name	Oxybenzone, Octinoxate, Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	7.5; 3.5; 44
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	OCTINOXATE; OXYBENZONE; PETROLATUM
Labeler Name	CVS
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 69842-0552-02 (69842055202)

Pricing Information	N/A
NDC Package Code	69842-552-02
Billing NDC	69842055202
Package	1 g in 1 CONTAINER (69842-552-02)
Marketing Start Date	2015-08-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e49680bd-bd61-40cf-abc8-51a1c8808726 Details

Active ingredient

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (44.0%)

Purpose

Sunscreen, Sunscreen, Skin Protectant

Keep Out of Reach of Children

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

Uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Warnings

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 prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140)..

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

CVS HEALTH ORIGINAL SPF 15 LIP BALM

oxybenzone, octinoxate, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-552
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.5 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	44.0 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)	18.00 mg in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	3.00 mg in 1 g
LANOLIN (UNII: 7EV65EAW6H)	1 mg in 1 g
CERESIN (UNII: Q1LS2UJO3A)	17.3 mg in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	.900 mg in 1 g

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-552-01	1 g in 1 CONTAINER; Type 0: Not a Combination Product	08/17/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/17/2015

Labeler - CVS (062312574)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(69842-552) , LABEL(69842-552)

Revised: 9/2016

Document Id: e49680bd-bd61-40cf-abc8-51a1c8808726

Set id: e49680bd-bd61-40cf-abc8-51a1c8808726

Version: 1

Effective Time: 20160914