Careline Skin Guard Kids by COSMOPHARM LTD. / Emilia Cosmetics Ltd Careline Skin Guard Kids

Drug Details [pdf]

CARELINE SKIN GUARD KIDS INVISIBLE SPF 50- homosalate,octocrylene,octisalate,avobenzone,oxybenzone spray
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.

----------

Careline Skin Guard Kids

Active ingredients

HOMOSALATE 10%

OCTOCRYLENE 10%

ETHYL SALICYLATE 5%

BUTYLBENZOYLMETHANE 5%

BENZOPHENONE-3 5%

Purpose

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

OCTOCRYLENE ........................................................Sunscreen

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

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

BENZOPHENONE-3 .....................................................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 entire body 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

Alcohol SD#40, Diethylhexyl 2,6 Naphthalate, Acrylates/Octylacrylamide Copolymer, Parfum, Tocopheryl Acetate (Vitamin E), Diethylhexyl Syringylidenemalonate, Caprylic/Capric Triglyceride, Coumarin, Hydroxycitronellal, Hydroxyisohexyl-3-Cyclohexene Carboxaldehyde, Citronellol. 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 kids

SPF 50

Clear spray sunscreen for kids

Easy to use disperse uniformly on the skin

UVA UVB Protection

Gives freshness effect

Rapid absorption Sweat resistant and water resistant

Oil free Hypoallergenic

Gas free Paraben free

Net Wt. 8.8 fl oz. 260 ml (225 gr.)

NDC: 69939-626-01

CARELINE SKIN GUARD KIDS INVISIBLE SPF 50
homosalate,octocrylene,octisalate,avobenzone,oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-626
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COUMARIN (UNII: A4VZ22K1WT)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69939-626-01	225 g in 1 TUBE; Type 0: Not a Combination Product	09/30/2015	09/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/30/2015	09/01/2019

Labeler - COSMOPHARM LTD. (600395487)

Name	Address	ID/FEI	Business Operations
Establishment
Emilia Cosmetics Ltd		600076624	manufacture(69939-626)

Revised: 8/2019

Document Id: 90b7d286-420b-66a5-e053-2a95a90a398b

Set id: 618f6d68-2f10-426d-914b-07083401951a

Version: 3

Effective Time: 20190822