Drug Facts

Active ingredients

Lanolin 24.91%

Avobenzone 2.5%

Octinoxate 7%

Purposes

Skin Protectant

Sunscreen

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

Warnings

For external use only.

Do not use

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

When using this product

keep out of 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
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

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

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

SUN PROTECTION
lanolin, avobenzone, octinoxate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82806-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	249.1 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 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)
COCOA BUTTER (UNII: 512OYT1CRR)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
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:82806-002-01	1 in 1 CARTON	09/01/2022
1		40 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	M016	09/01/2022

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

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

Name	Address	ID/FEI	Business Operations
Establishment
MAKRA KOZMETIKA D.O.O.		537064093	manufacture(82806-002)