Careline Perfect Care by COSMOPHARM LTD. / Emilia Cosmetics Ltd Careline Perfect Care

Drug Details [pdf]

CARELINE PERFECT CARE BB- titanium dioxide,octinoxate,allantoin,talc,caffeine 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 Perfect Care

Active ingredients

TITANIUM DIOXIDE 2.5%

ETHYLHEXYL METHOXYCINNAMATE 4%

ALLANTOIN 0.2%

TALC 2.5%

CAFFEINE 0.2%

Purpose

TITANIUM DIOXIDE .........................................................SUNSCREEN

ETHYLHEXYL METHOXYCINNAMATE..............................SUNSCREEN

ALLANTOIN......................................................................SKIN PROTECTANT

TALC................................................................................SKIN PROTECTANT

CAFFEINE.........................................................................SKIN PROTECTANT

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

Purified Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Glyceryl Myristate, Cyclopentasiloxane, Isononyl Isononanoate, Butylene Glycol, Glycerine, Propylene Glycol, Behenyl Alcohol, Mineral Oil, Microcrystalline Cellulose, Cellulose Gum, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Phenoxyethanol, Ethylhexylglycerin, Nylon-12, Parfum, Ammonium Acryloyldimethyllaurate/VP Copolymer, Triethanolamine, Ascorbyl Glucoside, Disodium EDTA, Tocopheryl Acetate (Vitamin E), Tetrapeptide - 26, BHT, Hyaluronic Acid, Citral. May Contain: Cl 77491, Cl 77492, Cl 77499, Cl 77891.

Other information:

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

Questions?

845-501-0127

Principal Display Panel

Careline

Perfect Care

BB cream

SPF 15

Moisturizing cream combined with color

Provides ongoing moisture
Conceals blemishes
Lightens the appearance of skin spots
Smooths the appearance of fine lines
Skin tone is even and radiant
For a perfect look instantly
Dermatologist tested
Non-comedogenic
Paraben-free

medium

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

CARELINE PERFECT CARE BB
titanium dioxide,octinoxate,allantoin,talc,caffeine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-645
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.2 g in 100 g
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U)	TALC	2.5 g in 100 g
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	0.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRICAPRIN (UNII: O1PB8EU98M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MYRISTATE (UNII: 6992Y81827)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DOCOSANOL (UNII: 9G1OE216XY)
MINERAL OIL (UNII: T5L8T28FGP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NYLON-12 (UNII: 446U8J075B)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
TROLAMINE (UNII: 9O3K93S3TK)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONIC ACID (UNII: S270N0TRQY)
CITRAL (UNII: T7EU0O9VPP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69939-645-02	50 g in 1 TUBE; Type 0: Not a Combination Product	09/17/2015	09/01/2019

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

Labeler - COSMOPHARM LTD. (600395487)

Name	Address	ID/FEI	Business Operations
Establishment
Emilia Cosmetics Ltd		600076624	manufacture(69939-645)

Revised: 8/2019

Document Id: 90b7d286-4229-66a5-e053-2a95a90a398b

Set id: 658b03f0-4c75-4761-a9b3-5671600ce7ce

Version: 4

Effective Time: 20190822