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NDC 68062-9099-01 Pharmaskincare Solar-C Moisturizer SPF 30 0.2625 mg/2.5mL Details

Pharmaskincare Solar-C Moisturizer SPF 30 0.2625 mg/2.5mL

Pharmaskincare Solar-C Moisturizer SPF 30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Spa de Soleil. The primary component is TITANIUM DIOXIDE.

Product Information

NDC	68062-9099
Product ID	68062-9099_7e0d3502-14fd-8390-e053-2a91aa0ace24
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	Pharmaskincare Solar-C Moisturizer SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	titanium dioxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	0.2625
Active Ingredient Units	mg/2.5mL
Substance Name	TITANIUM DIOXIDE
Labeler Name	Spa de Soleil
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 68062-9099-01 (68062909901)

Pricing Information	N/A
NDC Package Code	68062-9099-1
Billing NDC	68062909901
Package	120 mL in 1 TUBE (68062-9099-1)
Marketing Start Date	2017-10-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5b3e068e-654c-8532-e053-2a91aa0aab95 Details

Active Ingredient

Titanium Dioxide 10.5%

Purpose

Sunscreen

Warnings

For external use only.
Do not use on broken or damaged skin
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor is rash or irritation occurs or lasts.
If swallowed, seek medical help or contact a poison control center right away.
Keep out of reach of children.

Directions

Apply every morning as a daily moisturizer. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under six months of age: consult a doctor before use.

Other Information

Protect the product in this container from excessive heat.

Uses:

Helps prevent sunburn. Higher SPF gives more sunburn protection. Designed for skin highly sensitive to sunburn. If used as directed with other sun protection measures (see Sun Alert) decreases the risk of skin cancer and early skin aging caused by the sun.

Sun Alert: Spending time in the use 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 such as limited time in the sun, especially from 10 a.m. to 2 p.m. Wear long pants, hats, sunglasses, and long-sleeve shirts.

Inactive Ingredients:

Water, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Titanium Dioxide, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Jojoba Esters, Polyhydroxystearic Acid, Carbomer, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Benzyl Alcohol, Disodium EDTA, Dehydroacetic Acid

Warning

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Pharmaskincare SolarC SPF 30

INGREDIENTS AND APPEARANCE

PHARMASKINCARE SOLAR-C MOISTURIZER SPF 30

titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68062-9099
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.2625 mg in 2.5 mL

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68062-9099-1	120 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/10/2017

Labeler - Spa de Soleil (874682867)

Name	Address	ID/FEI	Business Operations
Establishment
Spa de Soleil		874682867	manufacture(68062-9099)

Revised: 12/2018

Document Id: 7e0d3502-14fd-8390-e053-2a91aa0ace24

Set id: 5b3e068e-654c-8532-e053-2a91aa0aab95

Version: 3

Effective Time: 20181227