PROJECT SUNSCREEN (as PLD) - FOR ALL MINERAL SUNSCREEN ROLL-ON LOTION SPF-50 (72688-108) - DELIST

PROJECT SUNSCREEN FOR ALL MINERAL SUNSCREEN ROLL-ON by

Drug Labeling and Warnings

PROJECT SUNSCREEN FOR ALL 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 FOR ALL MINERAL SUNSCREEN ROLL-ON SPF-50- titanium dioxide, zinc oxide lotion 
PROJECT SUNSCREEN

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PROJECT SUNSCREEN (as PLD) - FOR ALL MINERAL SUNSCREEN ROLL-ON LOTION SPF-50 (72688-108) - 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.

KEEP OUT OF REACH OF CHILDREN. IF PRODUCTS IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

WARNINGS

WARNINGS

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 FOR ALL MINERAL SUNSCREEN ROLL-ON  SPF-50
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72688-108
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: 72688-108-11	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: 15231360-f837-17df-e063-6294a90a1ac1

34390-5

Set id: 2edee9bc-c94e-4e9d-893a-fcc7189c830b

Version: 6

Effective Time: 20240402