Careline Skin Guard by COSMOPHARM LTD. Careline Skin Guard

Careline Skin Guard by

Drug Labeling and Warnings

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

Drug Details [pdf]

CARELINE SKIN GUARD SPF 30- oxybenzone,homosalate,octisalate,avobenzone,octocrylene gel 
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 Skin Guard

Active ingredients

BENZOPHENONE-3    4%

HOMOSALATE    10%

ETHYL SALICYLATE    5%

BUTYLBENZOYLMETHANE    15%

OCTOCRYLENE    2%

Purpose

BENZOPHENONE-3 .....................................................Sunscreen  

HOMOSALATE        .....................................................Sunscreen

ETHYL SALICYLATE    .................................................Sunscreen

BUTYLBENZOYLMETHANE   ........................................Sunscreen

OCTOCRYLENE    ........................................................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 eyes 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:

• Apply liberally to face and neck 15 minutes before sun exposure.
  
• Reapply:
  
• At least every 2 hours
• Immediately after towel drying
• After 80 minutes of swimming or sweating

Children under 6 month - ask a doctor

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.

Inactive ingredients

Isododecane, Dimethicone, Bis-Isobutyl PPG-20 Crosspolymer, Dicapryl Ether, Tocopheryl Acetate (Vitamin E), Astaxanthin, Plukenetia Volubilis Seed Oil, Tocopherol.

*Contains Oxybenzone.

Other information:

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

Questions?

845-501-0127

Principal Display Panel

Careline

SKIN GUARD

invisible

SPF 30

Clear Gel Face Protection

Clear formula that wont leave any white marks on your skin

Makes skin feel soft

Double Protection

Suitable for all skin types

Hypoallergenic

Paraben free

Water-resistant

Fragrance free

Net Wt. 2.1 fl oz. (60 ml) 48 gr.

NDC: 69939-051-01

CARELINE SKIN GUARD  SPF 30
oxybenzone,homosalate,octisalate,avobenzone,octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	15 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
BIS-ISOBUTYLENE PPG-20 (UNII: 5R9772B6IK)
DIDECYL ETHER (UNII: DA81HI310Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASTAXANTHIN (UNII: 8XPW32PR7I)
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69939-051-01	48 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/02/2015	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/02/2015	09/01/2019

Labeler - COSMOPHARM LTD. (600395487)

Revised: 8/2019

Document Id: 90b472dc-510e-f81d-e053-2a95a90a85c0

34390-5

Set id: cc4ad37b-eceb-49e5-8f51-74b4ec0877de

Version: 3

Effective Time: 20190822

 

COSMOPHARM LTD.