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:

Outer Package Inner Package

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
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)

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

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

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

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