Label: METHOD MEN FACE WITH ZINC OXIDE SUNSCREEN- zinc oxide lotion
- NDC Code(s): 52494-100-25
- Packager: Method Products Inc.
- 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 16, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
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
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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
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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
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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
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INGREDIENTS AND APPEARANCE
METHOD MEN FACE WITH ZINC OXIDE SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52494-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 6 g in 100 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52494-100-25 74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/10/2021 Labeler - Method Products Inc. (036514797) Establishment Name Address ID/FEI Business Operations AUTUMN HARP 064187883 MANUFACTURE(52494-100)
