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NDC 70793-0026-34 Zoey Naturals Unscented Broad Spectrum SPF 30 Sunscreen 18 g/100mL Details

Zoey Naturals Unscented Broad Spectrum SPF 30 Sunscreen 18 g/100mL

Zoey Naturals Unscented Broad Spectrum SPF 30 Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Absolutely Natural, Inc.. The primary component is ZINC OXIDE.

Product Information

NDC	70793-0026
Product ID	70793-026_fd08230b-2531-4bc8-82cf-7bf63688ff79
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	Zoey Naturals Unscented Broad Spectrum SPF 30 Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	18
Active Ingredient Units	g/100mL
Substance Name	ZINC OXIDE
Labeler Name	Absolutely Natural, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70793-0026-34 (70793002634)

Pricing Information	N/A
NDC Package Code	70793-026-34
Billing NDC	70793002634
Package	1 TUBE in 1 BOX (70793-026-34) / 100 mL in 1 TUBE
Marketing Start Date	2021-03-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba195c1d-e171-40b3-be7f-8dd87542b113 Details

Drug Facts

Active ingredient

Zinc Oxide 18%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early 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 doctor if rash occurs.

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

Directions •

• Apply liberally and evenly 15 minutes prior to sun exposure.

• Reapply after 40 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours.

• Children under 6 months of age: 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 •

• Protect this product from excessive heat and direct sun.

Inactive ingredients •

Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, helianthus annuus (sunflower) seed oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate.

Questions?

Call us! 800-848-8498

SPL UNCLASSIFIED SECTION

WATER RESISTANT (40 MINUTES)

BIODEGRADABLE, REEF SAFE, NO HARSH CHEMICALS

made for babies.

loved by mamas™

ZOEY naturals™ is formulated for babies and loved by mamas all around the world. Our effective and gentle formulas are free of harsh chemicals and safe on our environment.

ZOEY naturals™ BROAD SPECTRUM SPF 30 SUNSCREEN helps prevent sunburn and is infused with nutrients to keep your baby's skin nourished while in the sun.

Remember to reapply every 2 hours or after excessive sweating or swimming.

√ BIODEGRADABLE

√ NO HARSH CHEMICALS

√ REEF SAFE

√ WATER RESISTANT

Distributed by: Zoey Naturals

640 Atlantis Road, Melbourne, FL 32904

www.Zoey-Naturals.com

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Packaging

INGREDIENTS AND APPEARANCE

ZOEY NATURALS UNSCENTED BROAD SPECTRUM SPF 30 SUNSCREEN

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70793-026
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SHEA BUTTER (UNII: K49155WL9Y)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SAFFLOWER OIL (UNII: 65UEH262IS)
RASPBERRY (UNII: 4N14V5R27W)
SQUALANE (UNII: GW89575KF9)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70793-026-34	1 in 1 BOX	03/26/2021
1		100 mL 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 not final	part352	03/26/2021

Labeler - Absolutely Natural, Inc. (166425202)

Revised: 3/2021

Document Id: fd08230b-2531-4bc8-82cf-7bf63688ff79

Set id: ba195c1d-e171-40b3-be7f-8dd87542b113

Version: 1

Effective Time: 20210329