BABY MINERAL SUNSCREEN SPF55- zinc oxide lotion 
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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.

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Baby Mineral Sunscreen SPF55+

Drug Facts

Active Ingredients

Zinc Oxide 20.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on

broken or damaged skin

When using this product

Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

rash occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other Information

Inactive Ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis 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

HelloBello_sunscreen_dieline_109C_March2022_AO

BABY MINERAL SUNSCREEN SPF55 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL (UNII: 24WE03BX2T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHAMOMILE (UNII: FGL3685T2X)  
ORANGE OIL (UNII: AKN3KSD11B)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
TOCOPHEROL (UNII: R0ZB2556P8)  
VANILLA BEAN (UNII: Q74T35078H)  
WATER (UNII: 059QF0KO0R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
COCOA BUTTER (UNII: 512OYT1CRR)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO GLUCOSIDE (UNII: ICS790225B)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CUCUMBER (UNII: YY7C30VXJT)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
AVOCADO (UNII: SDS87L369F)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SHEA BUTTER (UNII: K49155WL9Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73418-100-0385.05 g in 1 TUBE; Type 0: Not a Combination Product07/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/28/2023
Labeler - Hello Bello (081135707)

Revised: 7/2023
Document Id: 0190eeaf-c5a1-3253-e063-6294a90a43c4
Set id: 0190eeaf-c5a0-3253-e063-6294a90a43c4
Version: 1
Effective Time: 20230728
 
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