DR. C. TUNA SUN PROTECTOR LIP BALM SPF 15- homosalate, octinoxate cream

Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15 by

Drug Labeling and Warnings

Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15 by is a Otc medication manufactured, distributed, or labeled by FARMASI US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredients:

Homosalate 4,45 %

Ethylhexyl Methoxycinnamate 3,45 %

Purpose:

Sunscreen

Uses:

• Helps prevent sunburn.

Warnings:

For external use only.

Do not use 

on damaged or broken skin.

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keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor 

if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Protects against UVB and UVA rays. This product does not provide 100% protection. Use physical protection (hat, t-shirt, glasses, etc.) Avoid long periods of sun exposure even if you are using sun protection. Keep babies and young children out of direct sunlight. The excessive sun exposure is a major health risk, Discontinue use if signs of irritation or rash occur. Aovid contact with eyes, may cause irritation. 

Directions:

Apply liberally 15 minutes before sun exposure - reapply at least every two hours. Apply morning and night, and as often as needed during the day. Reapply frequently on sun-centric days, and adventures. Children under 6 months of age: Ask a doctor. Apply before sun exposure. To maintain protection, apply frequently, especially after sweating, swimming or drying off. Apply sufficient amount to the skin. Sun Protection Measures:

Other information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

Polyisoprene, C18-70 Isoalkane, Caprylic/Capric Triglyceride, Olus Oil, Synthetic Beeswax, Ceresin, Cetyl Alcohol, Di-C12-15 Alkyl Fumarate, Butyrospermum Parkii Butter, Silica, Aroma/Flavour, Tocopheryl Acetate.

Questions or Comments?

info@farmasius.com (833) 432-7627 Monday - Friday (9 a.m. -9 p.m. EST)

Package Labeling: Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15, 15ml/0.5fl.oz

INGREDIENTS AND APPEARANCE

DR. C. TUNA SUN PROTECTOR LIP BALM SPF 15 
homosalate, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74690-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	44.5 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	34.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74690-030-00	1 in 1 BOX	01/05/2022
1		15 mL in 1 BOTTLE; 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	01/05/2022

Labeler - FARMASI US LLC (113303351)