FDA.reportPublic FDA data

Careline Skin Guard

Manufacturer
COSMOPHARM LTD.
Effective date
2019-08-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:14:49

Label at a glance#

ProductCareline Skin Guard SPF 30
Active ingredientOXYBENZONE, HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
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 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 su...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

BENZOPHENONE-3    4%

HOMOSALATE    10%

ETHYL SALICYLATE    5%

BUTYLBENZOYLMETHANE    15%

OCTOCRYLENE    2%


Purpose

OTC - PURPOSE SECTION

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

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

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

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

OCTOCRYLENE    ........................................................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 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

INACTIVE INGREDIENT SECTION

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

*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

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



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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
ASTAXANTHININACTIVE INGREDIENT8XPW32PR7I1
BIS-ISOBUTYLENE PPG-20INACTIVE INGREDIENT5R9772B6IK1
DIDECYL ETHERINACTIVE INGREDIENTDA81HI310Z1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ISODODECANEINACTIVE INGREDIENTA8289P68Y21
PLUKENETIA VOLUBILIS SEED OILINACTIVE INGREDIENT8ED72Z8J1Z1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81

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
69939-05169939-051-01

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
ISODODECANEA8289P68Y2IACT
DIMETHICONE92RU3N3Y1OIACT
BIS-ISOBUTYLENE PPG-205R9772B6IKIACT
DIDECYL ETHERDA81HI310ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ASTAXANTHIN8XPW32PR7IIACT
PLUKENETIA VOLUBILIS SEED OIL8ED72Z8J1ZIACT
TOCOPHEROLR0ZB2556P8IACT
OXYBENZONE95OOS7VE0YACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 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
90b472dc-510e-f81d-e053-2a95a90a85c0cc4ad37b-eceb-49e5-8f51-74b4ec0877de2019-08-22WarningsExact identifier
spl id: 90b472dc-510e-f81d-e053-2a95a90a85c0
spl set id: cc4ad37b-eceb-49e5-8f51-74b4ec0877de

Reported adverse events (FAERS/openFDA)#

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