Label: MENTHOLATUM NATURAL ICE SPORT SPF 30- avobenzone, dimethicone, octinoxate, octisalate ointment
-
NDC Code(s):
10742-8980-1,
10742-8980-2,
10742-8980-3,
10742-8980-4, view more10742-8980-5, 10742-8980-6
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
-
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
- Questions?
- Principal Display Panel
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MENTHOLATUM NATURAL ICE SPORT SPF 30
avobenzone, dimethicone, octinoxate, octisalate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8980 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) CERESIN (UNII: Q1LS2UJO3A) PETROLATUM (UNII: 4T6H12BN9U) TRICAPRIN (UNII: O1PB8EU98M) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCONUT OIL (UNII: Q9L0O73W7L) CALCIFEDIOL (UNII: P6YZ13C99Q) LEVOMENTHOL (UNII: BZ1R15MTK7) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8980-1 1 in 1 BLISTER PACK 03/29/2000 04/01/2019 1 4.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10742-8980-2 4.5 g in 1 TUBE; Type 0: Not a Combination Product 03/29/2000 04/01/2019 3 NDC:10742-8980-3 1 in 1 BLISTER PACK 04/02/2019 3 4.2 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:10742-8980-4 4.2 g in 1 TUBE; Type 0: Not a Combination Product 04/02/2019 5 NDC:10742-8980-5 1 in 1 BLISTER PACK 03/29/2000 5 4.5 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:10742-8980-6 4.5 g in 1 TUBE; Type 0: Not a Combination Product 03/29/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/29/2000 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-8980)