Label: BABY MINERAL SUNSCREEN PROBIOTICS SPF55- zinc oxide lotion
- NDC Code(s): 73418-101-03
- Packager: Hello Bello
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 28, 2023
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- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Apply liberally and spread evenly by hand 15 minutes before sun exposure
- Reapply: • after 80 minutes of swimming or sweating • immediately after towel use • at least every 2 hours
- For children under 6 months of age, ask a doctor
- Sun Protection Measures: Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses
- Other Information
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Inactive Ingredients
Water (Aqua), Cocos Nucifera (Coconut) Oil*, Butyloctyl Salicylate, Diheptyl Succinate, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter*, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium Stearoyl Glutamate, Cetearyl Alcohol, Microcrystalline Cellulose, Arachidyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Cetyl Alcohol, Caprylyl Glycol, Coco Glucoside, Behenyl Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyhydroxystearic Acid, Bisabolol*, Arachidyl Glucoside, Sodium Gluconate, Sodium Hyaluronate, Citric Acid, Triethyl Citrate, Glycerin, Caprylhydroxamic Acid, Cellulose Gum, Vanilla Planifolia Fruit Extract, Prunus Armeniaca (Apricot) Kernel Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Chamomilla Recutita (Matricaria) Flower Extract*, Avena Sativa (Oat) Kernel Oil, Bacillus Ferment, Persea Gratissima (Avocado) Fruit Extract*, Calendula Officinalis Flower Extract*, Cucumis Sativus (Cucumber) Fruit Extract*
*Organic
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INGREDIENTS AND APPEARANCE
BABY MINERAL SUNSCREEN PROBIOTICS SPF55
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) COCO GLUCOSIDE (UNII: ICS790225B) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) SODIUM GLUCONATE (UNII: R6Q3791S76) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) DOCOSANOL (UNII: 9G1OE216XY) CETYL ALCOHOL (UNII: 936JST6JCN) JOJOBA OIL (UNII: 724GKU717M) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) COCOA BUTTER (UNII: 512OYT1CRR) VANILLA (UNII: Q74T35078H) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CHAMOMILE (UNII: FGL3685T2X) GLYCERIN (UNII: PDC6A3C0OX) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) OAT KERNEL OIL (UNII: 3UVP41R77R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ORANGE OIL (UNII: AKN3KSD11B) COCONUT OIL (UNII: Q9L0O73W7L) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) AVOCADO (UNII: SDS87L369F) APRICOT KERNEL OIL (UNII: 54JB35T06A) LEVOMENOL (UNII: 24WE03BX2T) SHEA BUTTER (UNII: K49155WL9Y) CUCUMBER (UNII: YY7C30VXJT) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-101-03 85.05 g in 1 TUBE; Type 0: Not a Combination Product 07/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/28/2023 Labeler - Hello Bello (081135707)
