PROJECT SUNSCREEN (as PLD) - FESTIVAL MINERAL SUNSCREEN ROLL-ON LOTION SPF-40 (72688-105) - DELIST

PROJECT SUNSCREEN FESTIVAL MINERAL SUNSCREEN ROLL-ON by

Drug Labeling and Warnings

PROJECT SUNSCREEN FESTIVAL MINERAL SUNSCREEN ROLL-ON by is a Otc medication manufactured, distributed, or labeled by PROJECT SUNSCREEN, HealthSpecialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROJECT SUNSCREEN FESTIVAL MINERAL SUNSCREEN ROLL-ON SPF-40- titanium dioxide, zinc oxide lotion 
PROJECT SUNSCREEN

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PROJECT SUNSCREEN (as PLD) - FESTIVAL MINERAL SUNSCREEN ROLL-ON LOTION SPF-40 (72688-105) - DELIST

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 5%

ZINC OXIDE 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 PRODUCTS IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• shake well before use
• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if 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 10am–2pm
•    Wear long-sleeved shirts, pants, hats, and sunglasses

OTHER INFORMATION

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENTS

Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dicaprylyl Ether, Propanediol, Glycerin, Isostearic Acid, Polyhydroxystearic Acid, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Cetyl PEG/PPG-10/1
Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Sodium Chloride, Sodium Hyaluronate, Triethoxycaprylylsilane

QUESTIONS?

Call 424.262.9462, Monday – Friday, 9am – 5pm PST or visit projectsunscreen.com

PROJECT SUNSCREEN FESTIVAL MINERAL SUNSCREEN ROLL-ON  SPF-40
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72688-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72688-105-11	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/29/2020	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/29/2020	12/31/2023

Labeler - PROJECT SUNSCREEN (080823314)

Revised: 4/2024

Document Id: 1522e539-a94f-fcbd-e063-6294a90af3f9

34390-5

Set id: 9bd98d26-d2e9-430f-9aff-2dc7f2b06600

Version: 7

Effective Time: 20240402