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NDC 82117-0100-05 HATCH MAMA SUNNY MAMA Body Mineral Sunscreen Broad Spectrum SPF 50 12 g/100g Details

HATCH MAMA SUNNY MAMA Body Mineral Sunscreen Broad Spectrum SPF 50 12 g/100g

HATCH MAMA SUNNY MAMA Body Mineral Sunscreen Broad Spectrum SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Hatch Collection LLC. The primary component is ZINC OXIDE.

Product Information

NDC	82117-0100
Product ID	82117-100_db0cec60-1a96-2dbe-e053-2a95a90a0be3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	HATCH MAMA SUNNY MAMA Body Mineral Sunscreen Broad Spectrum SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	HATCH MAMA SUNNY MAMA Body Mineral Sunscreen Broad Spectrum SPF 50
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	12
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	Hatch Collection LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 82117-0100-05 (82117010005)

Pricing Information	N/A
NDC Package Code	82117-100-05
Billing NDC	82117010005
Package	1 TUBE in 1 CARTON (82117-100-05) / 150 g in 1 TUBE
Marketing Start Date	2022-02-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6cb8c622-d610-4c15-8c7f-9682df5dc589 Details

Active Ingredients

Zinc Oxide 12%

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

For external 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 docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• 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: Ask a doctor

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Coco-Caprylate, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Tridecyl Salicylate, Isopropyl Isostearate, Polyester-7, Squalane, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Polyglyceryl-3 Polyricinoleate, Silica Silylate, Glyceryl Dibehenate, Silica, Sodium Chloride, Tribehenin, Polyglyceryl-2 DiPolyhydroxystearate, Bisabolol, Phenylpropanol, Allantoin, Glyceryl Behenate, Lecithin, Caprylyl Glycol, Glycerin, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Tocopherol, Camellia Sinensis Leaf Extract.

Other Information

• protect the product in this container from excessive

heat and direct sun

Principal Display Panel

INGREDIENTS AND APPEARANCE

HATCH MAMA SUNNY MAMA BODY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50

hatch mama sunny mama body mineral sunscreen broad spectrum spf 50 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82117-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
COCO-CAPRYLATE (UNII: 4828G836N6)
PROPANEDIOL (UNII: 5965N8W85T)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
POLYESTER-7 (UNII: 0841698D2F)
SQUALANE (UNII: GW89575KF9)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
NEOPENTYL GLYCOL (UNII: QI80HXD6S5)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PHENYLPROPANOL (UNII: 0F897O3O4M)
BISABOLOL OXIDE A (UNII: 16AE65F94Y)
ALLANTOIN (UNII: 344S277G0Z)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
TOCOPHEROL (UNII: R0ZB2556P8)
CAMELLIA SINENSIS SEED (UNII: MRL49Z8AC4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82117-100-05	1 in 1 CARTON	02/22/2022
1		150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/22/2022

Labeler - Hatch Collection LLC (064833206)

Revised: 3/2022

Document Id: db0cec60-1a96-2dbe-e053-2a95a90a0be3

Set id: 6cb8c622-d610-4c15-8c7f-9682df5dc589

Version: 2

Effective Time: 20220325