Label: JOSIE MARAN - GET EVEN SUN MILK BROAD SPECTRUM SPF 33 MINERAL SUNSCREEN- titanium dioxide and zinc oxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 66163-4552-1, 66163-4552-2, 66163-4552-3, 66163-4552-4, view more66163-4552-5, 66163-4552-6 - Packager: Cosmetic Solutions LLC
- 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 May 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating:
- immediately after towel drying
- at least every two hours
- Children under 6 months: 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
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Inactive Ingredients
Water/Aqua/Eau1, Glycerin1, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride1, Ethyl Macadamiate1, Argania Spinosa (Argan) Kernel Oil2, Simmondsia Chinensis (Jojoba) Seed Oil1, Carthamus Tinctorius (Safflower) Seed Oil1, Hydrogenated Lecithin1, Squalane1, Bisabolol1, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate1, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Cocos Nucifera (Coconut) Oil1, Olea Europaea (Olive) Fruit Oil1, Xanthan Gum1, Oleic Acid1, Potassium Cetyl Phosphate1, Citric Acid, Althaea Officinalis (Marshmallow) Root Extract1, Calendula Officinalis Flower Extract1, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil1, Fragrance (Parfum)1, Tromethamine, Isopropyl Titanium Triisostearate, Argania Spinosa (Argan) Leaf Extract1, Silica1, Aminopropyl Triethoxysilane, Stearic Acid1, Ethylhexylglycerin, Lecithin1, Sclerotium Gum1, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract1, Pullulan1, Capryloyl Glycerin/Sebacic Acid Copolymer, Pleiogynium Timoriense (Burkedin Plum) Fruit Extract1, Podocarpus Elatus (Illawarra Plum) Fruit Extract1, Linalool, Biosaccharide Gum-41, Aloe Barbadensis (Aloe Vera) Leaf Juice2, Cetyl Alcohol, Limonene, Cinnamal, Tocopherol1.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
- PRINCIPAL DISPLAY PANEL - 2 mL Packet
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
JOSIE MARAN - GET EVEN SUN MILK BROAD SPECTRUM SPF 33 MINERAL SUNSCREEN
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66163-4552 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 3.15 g in 100 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 4.08 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Ethyl Macadamiate (UNII: ANA2NCS6V1) Argan Oil (UNII: 4V59G5UW9X) Jojoba Oil (UNII: 724GKU717M) Safflower Oil (UNII: 65UEH262IS) Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N) Squalane (UNII: GW89575KF9) Levomenol (UNII: 24WE03BX2T) Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248) Diheptyl Succinate (UNII: 057N7SS26Y) Phenoxyethanol (UNII: HIE492ZZ3T) Polyglyceryl-3 Pentaricinoleate (UNII: 7Q0OK5DOT4) Coconut Oil (UNII: Q9L0O73W7L) Olive Oil (UNII: 6UYK2W1W1E) Xanthan Gum (UNII: TTV12P4NEE) Oleic Acid (UNII: 2UMI9U37CP) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Citric Acid Monohydrate (UNII: 2968PHW8QP) Althaea Officinalis Root (UNII: TRW2FUF47H) Calendula Officinalis Flower (UNII: P0M7O4Y7YD) Castor Oil (UNII: D5340Y2I9G) Tromethamine (UNII: 023C2WHX2V) Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I) Argania Spinosa Leaf (UNII: 51XV5WTF7E) Silicon Dioxide (UNII: ETJ7Z6XBU4) 3-(Triethoxysilyl)Propylamine (UNII: L8S6UBW552) Stearic Acid (UNII: 4ELV7Z65AP) Ethylhexylglycerin (UNII: 147D247K3P) Betasizofiran (UNII: 2X51AD1X3T) Kakadu Plum (UNII: 0ZQ1D2FDLI) Pullulan (UNII: 8ZQ0AYU1TT) Capryloyl Glycerin/Sebacic Acid Copolymer (2000 MPA.S) (UNII: N7YC58165T) Pleiogynium Timoriense Fruit (UNII: AF3VFG6MLV) Podocarpus Elatus Fruit (UNII: R4N1M6CZCY) Linalool, (+/-)- (UNII: D81QY6I88E) Biosaccharide Gum-4 (UNII: 9XRL057X90) Aloe Vera Leaf (UNII: ZY81Z83H0X) Cetyl Alcohol (UNII: 936JST6JCN) Limonene, (+)- (UNII: GFD7C86Q1W) Cinnamaldehyde (UNII: SR60A3XG0F) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66163-4552-1 1 in 1 CARTON 10/01/2021 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:66163-4552-2 1 in 1 CARTON 10/01/2021 2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:66163-4552-3 1 in 1 CARTON 10/01/2021 3 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:66163-4552-4 2 mL in 1 PACKET; Type 0: Not a Combination Product 10/01/2021 5 NDC:66163-4552-5 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2021 01/01/2022 6 NDC:66163-4552-6 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 10/01/2021 Labeler - Cosmetic Solutions LLC (807907928)
