MENTHOLATUM NATURAL ICE PROTECT PLUS SPF 30 PROTECT PLUS SPF 30- avobenzone, dimethicone, octinoxate, octisalate stick

Mentholatum Natural Ice Protect Plus SPF 30 by

Drug Labeling and Warnings

Mentholatum Natural Ice Protect Plus SPF 30 by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%
Dimethicone 1%
Octinoxate 7.5%
Octisalate 5%

Purpose

Avobenzone - Sunscreen
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

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

Sun Protection Measures. 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 of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: ask a doctor

Other Information

• protect this product from excessive heat and direct sun

Inactive ingredients

mineral oil, ozokerite, petrolatum, tricaprin, fragrance, aloe barbadensis leaf extract, cocos nucifera (coconut) oil, cholecalciferol [vitamin D3], menthol, retinyl palmitate [vitamin A], tocopheryl acetate [vitamin E], zea mays (corn) oil

Questions?

1-877-636-2677

MON-FRI 9AM to 5PM (EST)

mentholatum.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOLATUM NATURAL ICE PROTECT PLUS SPF 30  PROTECT PLUS SPF 30
avobenzone, dimethicone, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-3080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MENTHOL, (+)- (UNII: C6B1OE8P3W)
RETINYL PALMITATE (UNII: 1D1K0N0VVC)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
ZEA MAYS (CORN) OIL (UNII: 8470G57WFM)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
TRICAPRIN (UNII: O1PB8EU98M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
FRAGRANCE 13576 (UNII: 5EM498GW35)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-3080-1	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(10742-3080)