TINTED LIP SHIELD- zinc oxide and homosalate cream 
OneKind.25

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Tinted Lip Shield

Active Ingredients

Homosalate 8 %

Zinc Oxide 5.6 %

Purpose

Sunscreen

Indication & Usage

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


Do not use on damaged or
broken skin.


Do not use on damaged or
broken skin.

When using this product keep out of eyes

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 generously
15 minutes before sun
exposure. Reapply at least
every 2 hours. Use a
water-resistant sunscreen if
swimming or sweating.
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


Protect the product in this
container from excessive heat
and direct sun.


Inactive Ingredients
helianthus annuus (sunflower)
seed oil, ricinus communis
(castor) seed oil, cocos nucifera
(coconut) oil, polyhydroxystearic
acid, simmondsia chinensis
(jojoba) seed oil, euphorbia
cerifera (candelilla) wax,
butyrospermum parkii (shea) nut
extract, squalane, jojoba esters,
rhus verniciflua peel wax,
caprylic/capric triglyceride,
polyglyceryl-3 polyricinoleate,
isostearic acid, lecithin, ascorbyl
palmitate, glycerin, averrhoa
carambola fruit extract,
tocopherol, octyldodecanol,
sorbitan oleate, alumina,
magnesium oxide, flavor.
may contain (+/-): ci 77491 (iron
oxides), ci 77492 (iron oxides),
ci 77499 (iron oxides)

Tinted Lip Shield

TINTED LIP SHIELD 
zinc oxide and homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79356-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.6 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SHEANUT (UNII: 84H6HBP32L)  
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
GLYCERIN (UNII: PDC6A3C0OX)  
STAR FRUIT (UNII: G00N2E9394)  
TOCOPHEROL (UNII: R0ZB2556P8)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CASTOR OIL (UNII: D5340Y2I9G)  
JOJOBA OIL (UNII: 724GKU717M)  
CANDELILLA WAX (UNII: WL0328HX19)  
SQUALANE (UNII: GW89575KF9)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79356-203-021 in 1 CARTON03/25/2022
1NDC:79356-203-018.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/25/2022
Labeler - OneKind.25 (080286020)

Revised: 12/2023
Document Id: 0d9d19aa-c756-9ad4-e063-6394a90a79e9
Set id: db10d0b8-8f77-54ad-e053-2995a90a3e0f
Version: 2
Effective Time: 20231228
 
OneKind.25