Drug Facts - Mentholatum Natural Ice Protect + Spf 30

Drug Facts - Mentholatum Natural Ice Protect + Spf 30
SPL v1
SPL
SPL Set ID 3804a14b-be7c-a973-e063-6294a90ac7fc
Route
TOPICAL
Published
Effective Date 2024-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (50 mg) Avobenzone (30 mg) Dimethicone (10 mg)
Inactive Ingredients
Petrolatum Menthol, (+)- Retinyl Palmitate Aloe Barbadensis Leaf Zea Mays (corn) Oil Mineral Oil Ceresin Tricaprin .alpha.-tocopherol Acetate Cholecalciferol Cocos Nucifera (coconut) Oil Fragrance 13576

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

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

Purpose

Avobenzone - Sunscreen Dimethicone - Skin protectant Octinoxate - Sunscreen Octisalate - Sunscreen


Medication Information

Purpose

Avobenzone - Sunscreen

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Description

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

Uses
  • helps prevent sunburn
  • temporarily protects chapped or cracked lips
  • protect from the drying effects of wind and cold weather
Section 51945-4

Warnings

For external use only

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

Do Not Use

on damaged or broken skin

Questions?

1-877-636-2677

MON-FRI 9AM to 5PM (EST)

mentholatum.com

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

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

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.


Structured Label Content

Uses
  • helps prevent sunburn
  • temporarily protects chapped or cracked lips
  • protect from the drying effects of wind and cold weather
Section 51945-4 (51945-4)

Purpose

Avobenzone - Sunscreen

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Warnings

For external use only

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

Do Not Use (Do not use)

on damaged or broken skin

Questions?

1-877-636-2677

MON-FRI 9AM to 5PM (EST)

mentholatum.com

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 3%

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

Inactive Ingredients (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

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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 (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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