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NDC 36800-0956-28 MINERAL SUNSCREEN SPF 50 70; 47 mg/g; mg/g Details

MINERAL SUNSCREEN SPF 50 70; 47 mg/g; mg/g

MINERAL SUNSCREEN SPF 50 is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	36800-0956
Product ID	36800-956_bfe076fa-f220-2c46-e053-2a95a90acee4
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	MINERAL SUNSCREEN SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE, TITANIUM DIOXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	70; 47
Active Ingredient Units	mg/g; mg/g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	TOPCO ASSOCIATES LLC
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 36800-0956-28 (36800095628)

Pricing Information	N/A
NDC Package Code	36800-956-28
Billing NDC	36800095628
Package	42 g in 1 CONTAINER (36800-956-28)
Marketing Start Date	2020-10-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bfe076fa-f21f-2c46-e053-2a95a90acee4 Details

Active ingredients

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

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 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.

Keep out of reach of children.

If swallowed, 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
- 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 in this container from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

Inactive ingredients

beeswax, butyloctyl salicylate, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, silica

Label

Topcare Everyday Mineral Sunscreen Stick SPF 50

NDC 36800-956-28

1.5 oz (42 g)

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF 50

zinc oxide, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-956
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	47 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL ALCOHOL (UNII: 936JST6JCN)
CANDELILLA WAX (UNII: WL0328HX19)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
CERESIN (UNII: Q1LS2UJO3A)
WHITE WAX (UNII: 7G1J5DA97F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOSTEARIC ACID (UNII: X33R8U0062)
PARAFFIN (UNII: I9O0E3H2ZE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-956-28	42 g in 1 CONTAINER; Type 0: Not a Combination Product	10/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/19/2020

Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 4/2021

Document Id: bfe076fa-f220-2c46-e053-2a95a90acee4

Set id: bfe076fa-f21f-2c46-e053-2a95a90acee4

Version: 1

Effective Time: 20210413