MAKRA TATTOO SUNSCREEN and SKIN PROTECTANT OINTMENT Broad Spectrum SPF 30+

MAKRA TATTOO SUNSCREEN and SKIN PROTECTANT Broad Spectrum SPF 30 by

Drug Labeling and Warnings

MAKRA TATTOO SUNSCREEN and SKIN PROTECTANT Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by MAKRA KOZMETIKA D.O.O.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAKRA TATTOO SUNSCREEN AND SKIN PROTECTANT BROAD SPECTRUM SPF 30- avobenzone, lanolin, octinoxate ointment 
MAKRA KOZMETIKA D.O.O.

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MAKRA TATTOO SUNSCREEN and SKIN PROTECTANT OINTMENT Broad Spectrum SPF 30+

Drug Facts

Active ingredients

Avobenzone 2.5%

Lanolin 24.91%

Octinoxate 7%

Purposes

Sunscreen

Skin Protectant

Uses

• temporarily protects minor:
• cuts
• scrapes
• burns
• 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 ( ), decreases the risk of skin cancer and early skin aging caused by the sun. seeDirections

Warnings

For external use only.

Do not use

• on damaged or broken skin
• on deep or puncture wounds
• on animal bites
• on serious burns

When using this product 

do not get into eyes. Rinse with water to remove.

Stop use and ask a doctor if

• 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 15 minutes before sun exposure
• reappy 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.
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

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

Package Labeling:

MAKRA TATTOO SUNSCREEN AND SKIN PROTECTANT BROAD SPECTRUM SPF 30 
avobenzone, lanolin, octinoxate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82806-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	249.1 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ALMOND OIL (UNII: 66YXD4DKO9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LEVOMENOL (UNII: 24WE03BX2T)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
COUMARIN (UNII: A4VZ22K1WT)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
GERANIOL (UNII: L837108USY)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82806-003-01	1 in 1 CARTON	05/01/2023	12/31/2024
1		80 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2023	12/31/2024

Labeler - MAKRA KOZMETIKA D.O.O. (537064093)

Revised: 10/2024

Document Id: 252ac547-ecce-36d4-e063-6394a90aa61f

34390-5

Set id: 61b985ee-6251-4ba2-87fa-6573ce455d30

Version: 3

Effective Time: 20241023