Careline by COSMOPHARM LTD. / Emilia Cosmetics Ltd Careline

Careline by

Drug Labeling and Warnings

Careline by is a Otc medication manufactured, distributed, or labeled by COSMOPHARM LTD., Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARELINE  REVIVAL PLUS- octinoxate,octisalate,avobenzone cream 
COSMOPHARM LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Careline

Active ingredients

ETHYLHEXYL METHOXYCINNAMATE   7.5%

ETHYLHEXYL SALICYLATE   4.0%

BUTYL METHOXYDIBENZOYLMETHANE  2.0%

Purpose

ETHYLHEXYL METHOXYCINNAMATE...................................................Sunscreen

ETHYLHEXYL SALICYLATE...................................................................Sunscreen

BUTYL METHOXYDIBENZOYLMETHANE...............................................Sunscreen

Uses:

• helps prevent sunburn
• if used as directed with other sun protection measures (See directions) decreases the risk of cancer and early skin aging causes by the sun.
  

Warnings:

For external use only.

Do not use

• on damaged or broken skin.
  
• if you have known sensitivities to any one of the ingredients.
  

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

This cosmetic product should be used only for the purpose it was intended and according to its instructions. Do not ingest.

Directions:

For sunscreen use. Apply liberally to face and neck 15 minutes before sun exposure. Apply at least every 2 hours

Sun Protection Measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

• Limit your time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply immediately after towel drying.
  

Inactive ingredients:

Water, Cyclopentasiloxane, Glycerin, Caprylic/ Capric Triglyceride, Behentrimonium Methosulfate, Cetyl Alcohol, Butylene Glycol, Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Dicaprylyl Ether, Squalane, Lecithin, Soy Isoflavones, Polysorbate 80, Alcohol, Silica, Cetearyl Glucoside, PEG-40 Stearate, Myristyl Myristate, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate (Vitamin E), Niacinamide, Calcium Pantothenate, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben,Isobutylparaben, Parfum, Sorbitan Tristearate, Salvia Sclarea (Alina) Seed Oil, DMDM Hydantoin, Magnesium Gluconate, Zinc Gluconate, Stearamine, Bisabolol, Disodium EDTA, Hyaluronic Acid, Alpha Isomethyl Ionone, Benzyl Salicylate, Butylphenyl Methylpropional, Citronellol, Geraniol, Hexyl Cinnamal, Hydroxyisohexyl-3-Cyclohexene Carboxaldehyde, Limonene.

Other information:

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

Questions?

845-501-0127

Principal Display Panel

Careline

Revival +

Reconstructing Day Cream

SPF 15

Contains the Progeline peptide

Enriched with collagen, minerals and isoflavones

Hypoallergenic

Net Wt. 1.7 fl oz (50 ml) 50 gr.

NDC: 69939-408-03

CARELINE   REVIVAL PLUS
octinoxate,octisalate,avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SHEA BUTTER (UNII: K49155WL9Y)
DIDECYL ETHER (UNII: DA81HI310Z)
SQUALENE (UNII: 7QWM220FJH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOY ISOFLAVONES (UNII: 71B37NR06D)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PEG-40 STEARATE (UNII: ECU18C66Q7)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NIACINAMIDE (UNII: 25X51I8RD4)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
SALVIA SCLAREA SEED OIL (UNII: JK0RP5O3HW)
DMDM HYDANTOIN (UNII: BYR0546TOW)
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
STEARAMINE (UNII: FFV58UNY7O)
LEVOMENOL (UNII: 24WE03BX2T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYALURONIC ACID (UNII: S270N0TRQY)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69939-408-03	50 g in 1 TUBE; Type 0: Not a Combination Product	09/17/2015	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/17/2015	09/01/2019

Labeler - COSMOPHARM LTD. (600395487)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Cosmetics Ltd		600076624	manufacture(69939-408)

Revised: 8/2019

Document Id: 90b76cc0-3e5e-ac22-e053-2995a90afaf1

34390-5

Set id: 8bab7010-ae89-4a00-b56d-3dd8b3286f9d

Version: 3

Effective Time: 20190822