Storage and handling
Other information protect the product in this container from excessive heat and direct sun
Safe Harbor Natural Suncare
- Manufacturer
- Emilia Personal Care Inc
- Effective date
- 2021-11-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:29:26
Label at a glance#
ProductSafe Harbor Natural Suncare Broad Spectrum
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Titanium Dioxide 7.6%
Zinc Oxide 4.0%
OTC - PURPOSE SECTION
Purpose
Sunscreen
Sunscreen
INDICATIONS & USAGE SECTION
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 SECTION
Warnings - For external use only - Do not use on damaged or
broken skin - When using this product keep out of eyes. Rinse with
water to remove -
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.
DOSAGE & ADMINISTRATION SECTION
Directions -Apply liberally 15 minutes before sun exposure.
-Reapply -After 80 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.
STORAGE AND HANDLING SECTION
Other information protect the product in this container from
excessive heat and direct sun
INACTIVE INGREDIENT SECTION
Inactive ingredients water, caprylic/capric triglyceride, sesamum
indicum (sesame) seed oil, helianthus annuus
(sunflower) seed oil, glycerin, cetearyl alcohol,
cetearyl glucoside, simmondsia chinensis
(jojaba) seed oil, glyceryl stearate,
butyrosperum parkii (shea) butter, potassium
cetyl phosphate, phenoxyethanol, ethylhexylglycerin,
xanthan gum, PEG-40 stearate, trimethoxycaprylsilane, allantoin,
tocopherol acetate (vitamin E), panthenol (pro-vitamin B5),
bisabolol, hippophae rhamnoides oil, avena sativa (oat) kernel extract,
echinacea purpurea root extract, chamomilla recutita (matricaria) flower extract,
tilia vulgaris flower extract, melissa officinalis leaf extract,
aspalathus linearis leaf extract, sodium lactate, porphyra umbilicalis extract
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42421-875-15 | 2023-06-17 | C162847 | 48780-1 | 9d75b9cf-fbb7-f424-e053-dadaa90a57ce | Safe Harbor Natural Suncare |
| 42421-875-15 | 2023-01-30 | C162847 | 48780-1 | 9d75b9cf-fbb7-f424-e053-dadaa90a57ce | Safe Harbor Natural Suncare |
| 42421-875-15 | 2021-11-04 | C162847 | 48780-1 | 9d75b9cf-fbb7-f424-e053-dadaa90a57ce | Safe Harbor Natural Suncare |
| 42421-875-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fbb7-f424-e053-dadaa90a57ce | Safe Harbor Natural Suncare |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 1 | |
| ASPALATHUS LINEARIS LEAF | INACTIVE INGREDIENT | H7UGK1GJCU | 1 | |
| CETEARYL GLUCOSIDE | INACTIVE INGREDIENT | 09FUA47KNA | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| ECHINACEA PURPUREA ROOT | INACTIVE INGREDIENT | OS64WTR4KU | 1 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL 1-STEARATE | INACTIVE INGREDIENT | 258491E1RZ | 1 | |
| HIPPOPHAE RHAMNOIDES SEED OIL | INACTIVE INGREDIENT | T53SBG6741 | 1 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 1 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 1 | |
| MATRICARIA RECUTITA ROOT | INACTIVE INGREDIENT | BTG5H50X7F | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| MELISSA OFFICINALIS LEAF | INACTIVE INGREDIENT | 50D2ZE9219 | 1 | |
| OAT | INACTIVE INGREDIENT | Z6J799EAJK | 1 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 1 | |
| PEG-40 STEARATE | INACTIVE INGREDIENT | ECU18C66Q7 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PORPHYRA UMBILICALIS | INACTIVE INGREDIENT | 14AN0J70WO | 1 | |
| POTASSIUM CETYL PHOSPHATE | INACTIVE INGREDIENT | 03KCY6P7UT | 1 | |
| SESAME OIL | INACTIVE INGREDIENT | QX10HYY4QV | 1 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| SODIUM LACTATE | INACTIVE INGREDIENT | TU7HW0W0QT | 1 | |
| TILIA X EUROPAEA FLOWER | INACTIVE INGREDIENT | NHV2K1OUDH | 1 | |
| TRIMETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | FZ07E4LW2M | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Safe Harbor Natural Suncare Broad Spectrum
- TITANIUM DIOXIDE, ZINC OXIDE
- WATER
- MEDIUM-CHAIN TRIGLYCERIDES
- SESAME OIL
- GLYCERIN
- CETOSTEARYL ALCOHOL
- CETEARYL GLUCOSIDE
- JOJOBA OIL
- GLYCERYL 1-STEARATE
- SHEA BUTTER
- POTASSIUM CETYL PHOSPHATE
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- XANTHAN GUM
- PEG-40 STEARATE
- TRIMETHOXYCAPRYLYLSILANE
- ALLANTOIN
- .ALPHA.-TOCOPHEROL ACETATE
- PANTHENOL
- LEVOMENOL
- HIPPOPHAE RHAMNOIDES SEED OIL
- OAT
- ECHINACEA PURPUREA ROOT
- MATRICARIA RECUTITA ROOT
- TILIA X EUROPAEA FLOWER
- MELISSA OFFICINALIS LEAF
- ASPALATHUS LINEARIS LEAF
- SODIUM LACTATE
- PORPHYRA UMBILICALIS
- TITANIUM DIOXIDE
- ZINC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42421-875 | 42421-875-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| SODIUM LACTATE | SODIUM LACTATE | TU7HW0W0QT | INJECTION, SOLUTION / INFILTRATION | 0.17 %v/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SPRAY / TOPICAL | 540 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, EXTENDED RELEASE / ORAL | 0.37 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| SODIUM LACTATE | SODIUM LACTATE | TU7HW0W0QT | SUSPENSION / ORAL | 20 mg/1ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CREAM / TOPICAL | 3300 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, EMULSION / INTRAVENOUS | 1.1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | GEL / TOPICAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SUSPENSION / ORAL | 10170 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| GLYCERYL 1-STEARATE | GLYCERYL 1-STEARATE | 258491E1RZ | OINTMENT / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | AEROSOL, FOAM / TOPICAL | 10.87 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER / SUBLINGUAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg |
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 |
|---|---|---|---|---|---|---|
| fe52e0f1-a410-6a2e-e053-6294a90a2d25 | eae5eb5d-1a7a-4d75-b832-ce5b3f07955b | 2023-06-17 | Warnings | eae5eb5d-1a7a-4d75-b832-ce5b3f07955b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.