FDA.reportPublic FDA data

Sun Protection

Manufacturer
MAKRA KOZMETIKA D.O.O.
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:51:26

Label at a glance#

ProductSun Protection
Active ingredientLANOLIN, AVOBENZONE, OCTINOXATE
Label structure7 sections

Indications and uses

temporarily protects minor: temporarily protects chapped or cracked skin helps protect from the drying effects of wind and cold weather helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions • cuts • scrapes • burns

Dosage and administration

apply generously 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 value of 15 or higher and other sun protection measures including: Sun Protection Measures. children under 6 months of age:...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lanolin 24.91%

Avobenzone 2.5%

Octinoxate 7%

Purposes

OTC - PURPOSE SECTION

Skin Protectant

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor:
  • temporarily protects chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

• cuts

• scrapes

• burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged skin
  • on deep or punture wounds
  • on animal bites
  • on serious burns

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • children under 6 months of age: ask a doctor

• limit time in the sun, especially from 10 a.m.-2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, petrolatum, chocolate (Theobroma cacao) butter, calendula (Calendula officinalis) flower extract, almond (Prunus dulcis) oil, cetearyl alcohol, jojoba (simmondsia chinesis) seed oil,sodium benzoate, potassium sorbate, bisbolol, allantoin, tocopheryl acetate, sodium cetearyl sulfate, coumarin, sodium lauryl sulfate, linalool, citric acid, fragrance, cinnamyl alchohol, benzyl salicylate, geraniol.

Tattoo Care Sun Protection Sunscreen and Skin Protectant Ointment SPF 30+, 1.4 oz (40g) 82806-200-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tattoo Care Sun Protection Sunscreen and Skin Protectant Ointment SPF 30+, 1.4 oz (40g) 82806-200-01 outer imageTattoo Care Sun Protection Sunscreen and Skin Protectant Ointment SPF 30+, 1.4 oz (40g) 82806-200-01 outer imageTattoo Care Sun Protection Sunscreen and Skin Protectant Ointment SPF 30+, 1.4 oz (40g) 82806-200-01 inner imageTattoo Care Sun Protection Sunscreen and Skin Protectant Ointment SPF 30+, 1.4 oz (40g) 82806-200-01 inner image

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82806-00282806-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
COCOA BUTTER512OYT1CRRIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ALMOND OIL66YXD4DKO9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
JOJOBA OIL724GKU717MIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
LEVOMENOL24WE03BX2TIACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
COUMARINA4VZ22K1WTIACT
SODIUM LAURYL SULFATE368GB5141JIACT
LINALOOL, (+/-)-D81QY6I88EIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CINNAMYL ALCOHOLSS8YOP444FIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
GERANIOLL837108USYIACT
LANOLIN7EV65EAW6HACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB

Source Document#

Source XML

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
252a9b34-919e-506b-e063-6294a90a4902e60ca518-73cb-6165-e053-2995a90aa6ae2024-10-23WarningsExact identifier
spl id: 252a9b34-919e-506b-e063-6294a90a4902
spl set id: e60ca518-73cb-6165-e053-2995a90aa6ae

Reported adverse events (FAERS/openFDA)#

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