FDA.reportPublic FDA data

Careline Skin Guard Kids

Manufacturer
COSMOPHARM LTD. | Emilia Cosmetics Ltd
Effective date
2019-08-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:14:35

Label at a glance#

ProductCareline Skin Guard Kids Invisible SPF 50
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, OXYBENZONE
Label structure9 sections

Indications and 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.

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

HOMOSALATE    10%

OCTOCRYLENE    10%

ETHYL SALICYLATE    5%

BUTYLBENZOYLMETHANE    5%

BENZOPHENONE-3    5%

Purpose

OTC - PURPOSE SECTION

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

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

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

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

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

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.


Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

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


Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.


Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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:

SPL UNCLASSIFIED SECTION

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


Questions?

OTC - QUESTIONS SECTION

845-501-0127

Principal Display Panel

PACKAGE LABEL.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


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DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
.BETA.-CITRONELLOL, (R)-INACTIVE INGREDIENTP01OUT964K1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
COUMARININACTIVE INGREDIENTA4VZ22K1WT1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXM1
DIETHYLHEXYL SYRINGYLIDENEMALONATEINACTIVE INGREDIENT3V5U97P2481
HYDROXYCITRONELLALINACTIVE INGREDIENT8SQ0VA4YUR1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69939-62669939-626-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COUMARINA4VZ22K1WTIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 80 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
90b7d286-420b-66a5-e053-2a95a90a398b618f6d68-2f10-426d-914b-07083401951a2019-08-22WarningsExact identifier
spl id: 90b7d286-420b-66a5-e053-2a95a90a398b
spl set id: 618f6d68-2f10-426d-914b-07083401951a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.