Search by Drug Name or NDC

NDC 63645-0178-05 SPF 50 Sunscreen Stick 200 mg/g Details

SPF 50 Sunscreen Stick 200 mg/g

SPF 50 Sunscreen Stick is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is ZINC OXIDE.

Product Information

NDC	63645-0178
Product ID	63645-178_91bd6dbc-064a-4636-b334-0fc6431e3ec4
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	SPF 50 Sunscreen Stick
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/g
Substance Name	ZINC OXIDE
Labeler Name	OraLabs
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63645-0178-05 (63645017805)

Pricing Information	N/A
NDC Package Code	63645-178-05
Billing NDC	63645017805
Package	14 g in 1 CONTAINER (63645-178-05)
Marketing Start Date	2020-02-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 096abb78-28ba-4bb6-89f6-927296d69314 Details

Active ingredient

Zinc Oxide….20.0%

Purpose

Sunscreen

Keep Out of Reach of Children

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

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 doctor if rash occurs.

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 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-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Extract, Behenyl Behenate, Shea Butter, Caprylic/Capric Triglyceride, Coconut Oil, Candelilla Wax, Sunflower Oil, Sunflower Wax, Polyhydroxystearic Acid, Castor Oil, Jojoba Oil, Squalane, Cocoa Butter, Tocopherol (Vitamin E).

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SPF 50 SUNSCREEN STICK

zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-178
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)	395 mg in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	162 mg in 1 g
COCOA BUTTER (UNII: 512OYT1CRR)	57 mg in 1 g
SUNFLOWER OIL (UNII: 3W1JG795YI)	64 mg in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-178-05	14 g in 1 CONTAINER; Type 0: Not a Combination Product	02/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/24/2020

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-178) , LABEL(63645-178)

Revised: 11/2022

Document Id: 91bd6dbc-064a-4636-b334-0fc6431e3ec4

Set id: 096abb78-28ba-4bb6-89f6-927296d69314

Version: 2

Effective Time: 20221103