PROJECT SUNSCREEN BABY MINERAL SUNSCREEN ROLL-ON SPF-50: Package Insert and Label Information

PROJECT SUNSCREEN BABY MINERAL SUNSCREEN ROLL-ON SPF-50- titanium dioxide and zinc oxide lotion
PROJECT SUNSCREEN

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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

01b LBL_PS_Baby_SPF-50_Handprints_R2_Page_1
(click image for full-size original)

01b LBL_PS_Baby_SPF-50_Handprints_R2_Page_2
(click image for full-size original)
PROJECT SUNSCREEN BABY MINERAL SUNSCREEN ROLL-ON SPF-50
titanium dioxide, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72688-110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 5 g in 100 g
ZINC OXIDE (ZINC CATION) ZINC CATION 7 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
ALKYL (C12-15) BENZOATE
DICAPRYLYL ETHER
PROPANEDIOL
GLYCERIN
ISOSTEARIC ACID
POLYHYDROXYSTEARIC ACID (2300 MW)
PHENOXYETHANOL
BENZOIC ACID
ETHYLHEXYLGLYCERIN
GLYCERETH-2 COCOATE
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER
SODIUM CHLORIDE
HYALURONATE SODIUM
TRIETHOXYCAPRYLYLSILANE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72688-110-11 85 g in 1 BOTTLE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/29/2020
Labeler — PROJECT SUNSCREEN (080823314)
Establishment
Name Address ID/FEI Operations
VEGE-KURL, INC. 021072509 manufacture (72688-110)

Revised: 06/2020 PROJECT SUNSCREEN

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.