Label: MINERAL SUNSCREEN SPF 50- zinc oxide lotion
- NDC Code(s): 73418-102-05
- 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 August 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
-
Directions
Shake well before use
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
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:
- Limiting time in the sun, especially from 10a.m. - 2p.m.
- Wearing long-sleeved shirts, pants, hats and sunglasses
Children under six months: Ask a doctor
- Other Information
-
Inactive Ingredients
Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco Glucoside, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Fruit Extract*, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Persea Gratissima (Avocado) Fruit Extract*, Polyhydroxystearic Acid, Prunus Armeniaca (Apricot) Kernel Oil*, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water (Aqua) *Organic
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-102 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 ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) DOCOSANOL (UNII: 9G1OE216XY) LEVOMENOL (UNII: 24WE03BX2T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SHEA BUTTER (UNII: K49155WL9Y) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CHAMOMILE (UNII: FGL3685T2X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ORANGE OIL (UNII: AKN3KSD11B) COCO GLUCOSIDE (UNII: ICS790225B) COCONUT OIL (UNII: Q9L0O73W7L) CUCUMBER (UNII: YY7C30VXJT) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) GLYCERIN (UNII: PDC6A3C0OX) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) AVOCADO (UNII: SDS87L369F) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) APRICOT KERNEL OIL (UNII: 54JB35T06A) SODIUM GLUCONATE (UNII: R6Q3791S76) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) COCOA BUTTER (UNII: 512OYT1CRR) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) VANILLA BEAN (UNII: Q74T35078H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-102-05 141.75 g in 1 TUBE; Type 0: Not a Combination Product 07/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/30/2023 Labeler - Hello Bello (081135707)
