Malin And Goetz
FDA Label NDC 53634-254

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Malin + Goetz for the product Malin And Goetz (NDC 53634-254). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY:
MALIN+GOETZ INC.,
210 WEST 29TH ST.,
NEW YORK, NEW YORK 10001

Otc - Purpose

Active IngredientPurpose
avobenzone 3%sunscreen
homosalate 10%sunscreen
octinoxate 7.5%sunscreen
octisalate 5%sunscreen
oxybenzone 5%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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove

Otc - Stop Use

Stop use and ask a doctor if: Rash or irritation develops and lasts

Otc - 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

Directions

  • Apply generously and evenly 15 minutes before sun exposure to clean face
  • 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 of age: Ask a doctor. Smooth onto face and neck until thoroughly absorbed

Inactive Ingredients

Water (aqua), c12-15 alkyl ethylhexanoate, dimethicone, glycerin, vp/eicosene copolymer, phenoxyethanol, peg-20 methyl glucose sesquistearate, methyl glucose sesquistearate, cetyl alcohol, potassium cetyl phosphate, acrylates/c10-30 alkyl acrylate cross- polymer, peg-40 stearate, chlorph- enesin, polysorbate 80, cholesterol, ethylhexylglycerin, sodium benzoate, sodium hydroxide, disodium edta, methylisothiazolinone, panthenol, tetrahexyldecyl ascorbate, aloe barbadensis leaf juice powder, allantoin, tocopherol, camellia oleifera leaf extract, epilobium angustifolium flower/leaf/stem extract

Other Information

  • protect this product from excessive heat and direct sun

Questions Or Comments?

Visit www.malinandgoetz.com or call +1-212-244-7771, M-F, 9am-6pm EST

Principal Display Panel - 48 Ml Tube Carton

(MALIN+GOETZ)
spf 30 face moisturizer.

BROAD SPECTRUM SPF 30. ALL SKIN TYPES.
APOTHECARY AND LAB—FM-118-48.

BROAD SPECTRUM SPF 30 HELPS PROTECT AGAINST
SUN DAMAGE WHILE GREEN TEA ANTIOXIDANTS PRO-
VIDE PROTECTION AGAINST ENVIRONMENTAL TOXINS
AND FREE RADICALS. GENTLY MOISTURIZES AND BAL-
ANCES ALL SKIN TYPES. NATURAL FRAGRANCE AND
COLOR. DIRECTIONS: APPLY GENEROUSLY AND EVENLY TO
CLEAN FACE 15 MINUTES BEFORE SUN EXPOSURE. USE A
WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6
MONTHS OF AGE: ASK A DOCTOR. SMOOTH ONTO FACE AND
NECK UNTIL THOROUGHLY ABSORBED. WARNINGS: FOR EXT-
ERNAL 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 OR IRRITATION DEVELOPS AND LASTS. KEEP OUT OF
REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR
CONTACT A POISON CONTROL CENTER RIGHT AWAY. FORM-
ULATED AND DISTRIBUTED BY: MALIN+GOETZ INC., 210 WEST
29TH ST., NEW YORK, NEW YORK 10001, TEL +1 212 244 7771.
WWW.MALINANDGOETZ.COM. MALIN+GOETZ DOES NOT TEST
ON ANIMALS. MADE IN USA.

1.7fl.oz.℮48ml

Principal Display Panel (48 mL Tube Carton)

Principal Display Panel (48 mL Tube Carton)

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