Indications and 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.
Lip Shine SPF35 Sunscreen
- Manufacturer
- Colorescience
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:08
Label at a glance#
ProductLip Shine SPF35 Sunscreen
Active ingredientZinc Oxide
Label structure11 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Works best on moisturized skin. Reapply: After 40 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: 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 1...
Storage and handling
Protect this product from excessive heat and direct sun.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients
Zinc Oxide 6.6%
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.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
- Reapply:
- After 40 minutes of swimming or sweating.
- Immediately after towel drying.
- At least every 2 hours.
- Children under 6 months: 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 from 10 a.m.– 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredients
Phenyl Trimethicone, Bis-Vinyl Dimethicone/ Dimethicone Copolymer, Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Mica, Ethylhexyl Palmitate, Tocopheryl Acetate, Triethyl Citrate, Glyceryl Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Polyhydroxystearic Acid, Tribehenin, Sodium Hyaluronate, Palmitoyl Tripeptide-1, Sorbitan Isostearate, Tin Oxide, Flavor/Aroma, Limonene, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891), Carmine (CI 75470). Contains Carmine as a color additive.
Other information
Protect this product from excessive heat and direct sun.
Questions or comments?
Call toll free 866.426.5673
SPL UNCLASSIFIED SECTION
Distributed in USA
by Colorescience®
Carlsbad, CA 92011
PRINCIPAL DISPLAY PANEL - 4 mL Tube Carton
colorescience®
LIP
SHINE
Moisturizes & smooths lips
Defends against UV rays
Tint of color, natural shine
Water resistant
(40 minutes)
35
Broad Spectrum
SPF 35
Sunscreen
0.13 fl. oz. / 4 mL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68078-028-01 | 2021-10-08 | C162847 | 48780-1 | ba0f9c33-23cf-a910-e053-dadaa90a0b85 | Lip Shine SPF35 Sunscreen |
| 68078-028-02 | 2021-10-08 | C162847 | 48780-1 | ba0f9c33-23cf-a910-e053-dadaa90a0b85 | Lip Shine SPF35 Sunscreen |
| 68078-028-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-23cf-a910-e053-dadaa90a0b85 | Lip Shine SPF35 Sunscreen |
| 68078-028-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-23cf-a910-e053-dadaa90a0b85 | Lip Shine SPF35 Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68078-028-01 | Lip Shine SPF35 Sunscreen | 4 mL in 1 TUBE, WITH APPLICATOR | LIQUID | 4 | 3 | |
| 68078-028-01 | Lip Shine SPF35 Sunscreen | 1 in 1 CARTON | LIQUID | 1 | 3 | |
| 68078-028-02 | Lip Shine SPF35 Sunscreen | 1.7 mL in 1 TUBE, WITH APPLICATOR | LIQUID | 1.7 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Lip Shine SPF35 Sunscreen
- Zinc Oxide
- Phenyl Trimethicone
- Neopentyl Glycol Diheptanoate
- Disteardimonium Hectorite
- MICA
- Ethylhexyl Palmitate
- Triethyl Citrate
- Glyceryl Isostearate
- .ALPHA.-TOCOPHEROL ACETATE
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)
- POLYHYDROXYSTEARIC ACID (2300 MW)
- Tribehenin
- HYALURONATE SODIUM
- Palmitoyl Tripeptide-1
- Sorbitan Isostearate
- LIMONENE, (+)-
- STANNIC OXIDE
- FERRIC OXIDE RED
- FERROSOFERRIC OXIDE
- FERRIC OXIDE YELLOW
- CARMINIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68078-028 | 68078-028-01, 68078-028-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lip Shine SPF35 Sunscreen | ZINC OXIDE | Colorescience | 3a6506c4-1ba9-493a-a4c8-e5f9c60d221b | 2024-12-13 | Warnings | 68078-028-01 68078-028-02 68078-028 68078002802 68078002801 10c37e69-e203-43fb-a8c3-50be826a74f1 3a6506c4-1ba9-493a-a4c8-e5f9c60d221b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.