MENTHOLATUM NATURAL ICE - ORIGINAL, SPF 15 ORIGINAL- dimethicone, octinoxate, octisalate stick

Mentholatum Natural Ice - Original, SPF 15 by

Drug Labeling and Warnings

Mentholatum Natural Ice - Original, SPF 15 by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Dimethicone 1%
Octinoxate 7.5%
Octisalate 5%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Uses

• helps prevent sunburn
• temporarily protects chapped or cracked lips
• protect from the drying effects of wind and cold weather

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

on damaged or broken skin

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 liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: ask a doctor

Inactive ingredients

mineral oil, ozokerite, petrolatum, lanolin, fragrance, menthol

Questions?

1-877-636-2677

MON-FRI 9AM to 5PM (EST)

mentholatum.com

Other Information

• protect this product from excessive heat and direct sun

Package Label/Principal Display Panel

Package Label/Principal Display Panel

INGREDIENTS AND APPEARANCE

MENTHOLATUM NATURAL ICE - ORIGINAL, SPF 15  ORIGINAL
dimethicone, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-3070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
LANOLIN (UNII: 7EV65EAW6H)
MENTHOL (UNII: L7T10EIP3A)
PETROLATUM (UNII: 4T6H12BN9U)
FRAGRANCE 13576 (UNII: 5EM498GW35)
CERESIN (UNII: Q1LS2UJO3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-3070-1	1 in 1 BLISTER PACK	09/01/2024
1		4.2 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	09/01/2024

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	manufacture(10742-3070)