![MALIN AND GOETZ SPF 30 FACE MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) CREAM [MALIN + GOETZ]](https://medic.hrt.org//dailymed/images/86dda2da-c05f-4f26-a174-ca893709e003/malin-01.jpg)
| NDC | 53634-254-50 |
| Set ID | 86dda2da-c05f-4f26-a174-ca893709e003 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Malin + Goetz |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
- 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
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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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
MALIN AND GOETZ SPF 30 FACE MOISTURIZER
avobenzone, homosalate, octinoxate, octisalate, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53634-254 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 mL homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S) homosalate 100 mg in 1 mL octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate 75 mg in 1 mL octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate 50 mg in 1 mL oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) c12-15 alkyl ethylhexanoate (UNII: GQJ580CH83) dimethicone (UNII: 92RU3N3Y1O) glycerin (UNII: PDC6A3C0OX) phenoxyethanol (UNII: HIE492ZZ3T) peg-20 methyl glucose sesquistearate (UNII: 0345752X7U) cetyl alcohol (UNII: 936JST6JCN) potassium cetyl phosphate (UNII: 03KCY6P7UT) peg-40 stearate (UNII: ECU18C66Q7) chlorphenesin (UNII: I670DAL4SZ) polysorbate 80 (UNII: 6OZP39ZG8H) cholesterol (UNII: 97C5T2UQ7J) ethylhexylglycerin (UNII: 147D247K3P) sodium benzoate (UNII: OJ245FE5EU) sodium hydroxide (UNII: 55X04QC32I) edetate disodium (UNII: 7FLD91C86K) methylisothiazolinone (UNII: 229D0E1QFA) panthenol (UNII: WV9CM0O67Z) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) aloe vera leaf (UNII: ZY81Z83H0X) allantoin (UNII: 344S277G0Z) tocopherol (UNII: R0ZB2556P8) camellia oleifera leaf (UNII: 5077EL0C60) epilobium angustifolium flowering top (UNII: 08H094218D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53634-254-50 1 in 1 CARTON 1 48 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2014 Labeler - Malin + Goetz (138615930) Registrant - Milbar Laboratories,Inc. (195556790) Establishment Name Address ID/FEI Business Operations Milbar Laboratories,Inc. 195556790 MANUFACTURE(53634-254)