Label: TINTED LIP SHIELD- zinc oxide and homosalate cream
- NDC Code(s): 79356-203-01, 79356-203-02
- Packager: OneKind.25
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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 - OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
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)
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TINTED LIP SHIELD
zinc oxide and homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79356-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.6 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79356-203-02 1 in 1 CARTON 03/25/2022 1 NDC:79356-203-01 8.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/25/2022 Labeler - OneKind.25 (080286020)