Indications and uses
Help prevent sunburn.
Sunscreen Broad Spectrum SPF 55 Moisturizing Lotion
- Manufacturer
- Scarsdale Integrative Family Medicine Pllc
- Effective date
- 2021-01-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:37:16
Label at a glance#
ProductSunscreen Broad Spectrum SPF 55 Moisturizing
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure9 sections
Dosage and administration
Apply liberally and evenly 15 minutes before sun exposure. For children under 6 months of age: Ask a doctor. Reapply: At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours. 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 of 15 or high...
Storage and handling
Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
ACTIVE INGREDIENTS
Octinoxate 7.5%
Zinc Oxide 4.8%
PURPOSE
Sunscreen
USES
Help prevent sunburn.
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 or irritation occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS
Apply liberally and evenly 15 minutes before sun exposure. 1Reapply:
At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours.
- 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 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-sleeve shirts, pants, hats, and sunglasses.
1 For children under 6 months of age: Ask a doctor.
INACTIVE INGREDIENTS
Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.
OTHER INFORMATION
Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.
See Beyond
Scarsdale Aesthetic Medicine
Dynamic Broad Spectrum
Snscreen SPF 55
Sun Protection
1.75 fl Oz (50ml)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81413-5550-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3b8b-0266-e053-dadaa90a7c1a | Sunscreen Broad Spectrum SPF 55 Moisturizing Lotion |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81413-5550-2 | Sunscreen Broad Spectrum SPF 55 Moisturizing | 50 g in 1 BOTTLE, PLASTIC | CREAM | 50 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 81413-5550 | SUNSCREEN BROAD SPECTRUM SPF 55 MOISTURIZING (OCTINOXATE AND ZINC OXIDE) CREAM [SCARSDALE INTEGRATIVE FAMILY MEDICINE PLLC] | 1 | Legacy NDC, 1 package rows | 20210126_b9856818-4e23-ebfe-e053-2a95a90a6b4e.zip |
Products#
Every source-derived product name is available through these pages.
- Sunscreen Broad Spectrum SPF 55 Moisturizing
- Octinoxate and Zinc Oxide
- WATER
- ISOCETYL STEARATE
- SORBITOL
- CETOSTEARYL ALCOHOL
- CYCLOMETHICONE 5
- GLYCERYL MONOSTEARATE
- PEG-100 STEARATE
- ALCOHOL
- OCTISALATE
- POLYOXYL 20 CETOSTEARYL ETHER
- .ALPHA.-TOCOPHEROL ACETATE
- VINYLPYRROLIDONE/EICOSENE COPOLYMER
- HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
- ETHYLHEXYLGLYCERIN
- BETULA PUBESCENS BARK
- GARDEN CRESS SPROUT
- SAGE
- COLA ACUMINATA SEED
- CAMELLIA OLEIFERA LEAF
- ALOE VERA LEAF
- XANTHAN GUM
- ISOMALT
- EDETATE DISODIUM ANHYDROUS
- TRIETHOXYCAPRYLYLSILANE
- SODIUM BENZOATE
- CAPRYLYL GLYCOL
- PHENOXYETHANOL
- OCTINOXATE
- ZINC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81413-5550 | 81413-5550-2 |
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 |
|---|---|---|---|---|---|---|
| b985508d-a428-2d40-e053-2a95a90a3ab6 | b9856818-4e23-ebfe-e053-2a95a90a6b4e | 2021-01-22 | Warnings | b985508d-a428-2d40-e053-2a95a90a3ab6 b9856818-4e23-ebfe-e053-2a95a90a6b4e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.