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NDC 62839-1254-01 Nu Skin 180 Degree UV Defense Hydrator SPF 18 75; 54 mg/mL; mg/mL Details

Nu Skin 180 Degree UV Defense Hydrator SPF 18 75; 54 mg/mL; mg/mL

Nu Skin 180 Degree UV Defense Hydrator SPF 18 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by NSE Products, Inc.. The primary component is OCTINOXATE; ZINC OXIDE.

Product Information

NDC	62839-1254
Product ID	62839-1254_7de36c3b-55e3-450f-92de-8df56d0a2ec0
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	Nu Skin 180 Degree UV Defense Hydrator SPF 18
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate and Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	75; 54
Active Ingredient Units	mg/mL; mg/mL
Substance Name	OCTINOXATE; ZINC OXIDE
Labeler Name	NSE Products, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62839-1254-01 (62839125401)

Pricing Information	N/A
NDC Package Code	62839-1254-1
Billing NDC	62839125401
Package	1 BOTTLE, PLASTIC in 1 CARTON (62839-1254-1) / 30 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2013-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 91a22a5a-87fd-4db0-9183-caebee401304 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate (7.5%), Zinc Oxide (5.4%)

Purpose

Sunscreen

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.
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.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

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

Directions

Use in the morning as the fourth step in the Nu Skin 180°® System. Apply lightly in an upward, outward motion to face

Apply lightly in an upward, outward motion to face and neck, avoiding the eye area.
Sunprotection 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. –2p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
Children under 6 months: Ask a doctor.

Inactive Ingredients

Water (Aqua), Ethylhexyl Isononanoate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Methylpropanediol, Pentylene Glycol, Octyldodecyl Neopentanoate, Ceteth-20, Cyclohexasiloxane, Dimethicone, Trilaureth-4 Phosphate, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Di-C12-15 Alkyl Fumarate, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Lecithin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Stearyl Glycyrrhetinate, Panthenol, Plankton Extract, Steareth-20, Polyhydroxystearic Acid, Butylene Glycol, PEG-75 Stearate, Isostearic Acid, p-Anisic Acid, Xanthan Gum, Disodium EDTA, Citric Acid, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin.

Other Information

Protect this product from excessive heat and direct sun.

Questions?

1-888-742-7626

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

Nu Skin

180°®

UV Defense Hydrator

Broad Spectrum

SPF 18

30 ml e (1 fl. oz.)

Principal Display Panel - 30 ml Bottle Carton

INGREDIENTS AND APPEARANCE

NU SKIN 180 DEGREE UV DEFENSE HYDRATOR SPF 18

octinoxate and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-1254
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	54 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Methylpropanediol (UNII: N8F53B3R4R)
Pentylene Glycol (UNII: 50C1307PZG)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Ceteth-20 (UNII: I835H2IHHX)
Cyclomethicone 6 (UNII: XHK3U310BA)
Dimethicone (UNII: 92RU3N3Y1O)
Trilaureth-4 Phosphate (UNII: M96W2OLL2V)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Di-C12-15 Alkyl Fumarate (UNII: A1CB3Z898P)
Avocado Oil (UNII: 6VNO72PFC1)
Shea Butter (UNII: K49155WL9Y)
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
Stearyl Glycyrrhetinate (UNII: 3YYE6VJS0P)
Panthenol (UNII: WV9CM0O67Z)
Steareth-20 (UNII: L0Q8IK9E08)
Butylene Glycol (UNII: 3XUS85K0RA)
PEG-75 Stearate (UNII: OT38R0N74H)
Isostearic Acid (UNII: X33R8U0062)
p-Anisic Acid (UNII: 4SB6Y7DMM3)
Xanthan Gum (UNII: TTV12P4NEE)
Edetate Disodium (UNII: 7FLD91C86K)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Chlorphenesin (UNII: I670DAL4SZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62839-1254-1	1 in 1 CARTON	08/01/2013
1		30 mL in 1 BOTTLE, PLASTIC; 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	08/01/2013

Labeler - NSE Products, Inc. (803486393)

Revised: 1/2022

Document Id: 7de36c3b-55e3-450f-92de-8df56d0a2ec0

Set id: 91a22a5a-87fd-4db0-9183-caebee401304

Version: 3

Effective Time: 20220110