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NDC 52494-0100-25 Method Men Face with Zinc Oxide Sunscreen 6 g/100mL Details

Method Men Face with Zinc Oxide Sunscreen 6 g/100mL

Method Men Face with Zinc Oxide Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Method Products Inc.. The primary component is ZINC OXIDE.

Product Information

NDC	52494-0100
Product ID	52494-100_6c0bc222-9b01-4eb6-90e8-cdcac1e06e78
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Method Men Face with Zinc Oxide Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	6
Active Ingredient Units	g/100mL
Substance Name	ZINC OXIDE
Labeler Name	Method Products Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52494-0100-25 (52494010025)

Pricing Information	N/A
NDC Package Code	52494-100-25
Billing NDC	52494010025
Package	74 mL in 1 BOTTLE, PLASTIC (52494-100-25)
Marketing Start Date	2021-01-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cce5f8e1-cf40-4524-af2b-1d49309e2809 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zinc Oxide 6%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

for sunscreen use
apply liberally 15 minutes before sun exposure
reapply at least eveary 2 hours
use a water resistant sunscreen if swimming or sweating
children under 6 months of age: ask a doctor
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 value 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-sleeved shirts, pants, hats, and sunglasses.

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, caprylic/capric triglyceride1, cocos nucifera (coconut) oil1, sorbitan stearate1, glycerin1, heptyl undecylenate1, magnesium aluminum silicate1, jojoba esters/helianthus annuus (sunflower) seed wax/acacia decurrens flower wax/polyglycerin-31, phenoxyethanol, simmondsia chinensis (jojoba) seed oil1, sucrose cocoate1, xanthan gum1, citric acid1, lecithin1, polyhydroxystearic acid1, titanium dioxide (CI 77891), cannabis sativa seed oil1, tocopheryl (vitamin e) acetate1.

1: Denotes plant or mineral origin.

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

method®

men

FACE LOTION

WITH ZINC OXIDE SUNSCREEN

BROAD SPECTRUM SPF 15

infused with vitamin E

+ hemp seed oil

fragrance free

74 mL (2.5 FL OZ)

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

INGREDIENTS AND APPEARANCE

METHOD MEN FACE WITH ZINC OXIDE SUNSCREEN

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52494-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	6 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
GLYCERIN (UNII: PDC6A3C0OX)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
JOJOBA OIL (UNII: 724GKU717M)
SUCROSE COCOATE (UNII: 3H18P0UK73)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
1-PALMITOYL-2-LINOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 6UCA7I41S8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-100 STEARATE (UNII: YD01N1999R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52494-100-25	74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/10/2021

Labeler - Method Products Inc. (036514797)

Name	Address	ID/FEI	Business Operations
Establishment
AUTUMN HARP		064187883	MANUFACTURE(52494-100)

Revised: 2/2022

Document Id: 6c0bc222-9b01-4eb6-90e8-cdcac1e06e78

Set id: cce5f8e1-cf40-4524-af2b-1d49309e2809

Version: 1

Effective Time: 20220216